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Sign in to subscribeAs of 13 November 2026, for Vardenafil Hydrochloride Tablets, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 15 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 3 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 2 of 2 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| LEVITRA | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 021400 · Product no. 001, 002, 003, 004 | TABLET | ORAL | DISCONTINUED | 2003/08/19 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| STAXYN | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 200179 · Product no. 001 | TABLET, ORALLY DISINTEGRATING | ORAL | DISCONTINUED | 2010/06/17 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Loaded records: 15 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20264800 | 2026/06/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20264799 | 2026/06/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | 2026/03/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20256414 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20256415 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20254953 | 2025/07/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20254173 | 2025/05/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | 2025/05/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | 2025/05/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20249572 | 2024/12/01 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized | Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H20249431 | 2024/11/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized | Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized | 国药准字H20249029 | 2024/10/09 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Pioneer Pharmaceutical Co., Ltd | Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243123 | 2024/01/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243124 | 2024/01/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yangtze River Pharmaceutical Group Co., Ltd | Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233768 | 2023/06/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690 | 2023/06/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339 | 2020/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | 2020/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Bayer AG | Bayer AG | H20140495;H20140497 | 2004/08/05 | 20mg | Imported originator drug | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
Loaded records: 16 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20254173 | See source | Not stated by source | XG04BEF001A001010100475 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010101503 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233768 | See source | Not stated by source | XG04BEF001A001010101749 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010102180 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001010104131 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | See source | Not stated by source | XG04BEF001A001010104339 | NHSA |
| Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized | 国药准字H20249029 | See source | Not stated by source | XG04BEF001A001010104578 | NHSA |
| Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H20249431 | See source | Not stated by source | XG04BEF001A001010104873 | NHSA |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690 | See source | Not stated by source | XG04BEF001A001010105134 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010183087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010183521 | NHSA |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123 | See source | Not stated by source | XG04BEF001A001010183946 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010201503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010202180 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001010204131 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | See source | Not stated by source | XG04BEF001A001010204339 | NHSA |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690 | See source | Not stated by source | XG04BEF001A001010205134 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010283087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010283521 | NHSA |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123 | See source | Not stated by source | XG04BEF001A001010283946 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010301503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010302180 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | See source | Not stated by source | XG04BEF001A001010304339 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010383087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010383521 | NHSA |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123 | See source | Not stated by source | XG04BEF001A001010383946 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010401503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010402180 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | See source | Not stated by source | XG04BEF001A001010404339 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010483087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010483521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010501503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010502180 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792 | See source | Not stated by source | XG04BEF001A001010504339 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010583087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010583521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010601503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010602180 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010683087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010683521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010701503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010702180 | NHSA |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572 | See source | Not stated by source | XG04BEF001A001010783087 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010783521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010801503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010802180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010883521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001010901503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001010902180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001010983521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011001503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338 | See source | Not stated by source | XG04BEF001A001011002180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011083521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011101503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011183521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011201503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011283521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011301503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011383521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011401503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011483521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011501503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011583521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130 | See source | Not stated by source | XG04BEF001A001011601503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001011983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001012983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715 | See source | Not stated by source | XG04BEF001A001013583521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020101503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339 | See source | Not stated by source | XG04BEF001A001020102180 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001020104131 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020183521 | NHSA |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243124 | See source | Not stated by source | XG04BEF001A001020183946 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020201503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339 | See source | Not stated by source | XG04BEF001A001020202180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020283521 | NHSA |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243124 | See source | Not stated by source | XG04BEF001A001020283946 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020301503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339 | See source | Not stated by source | XG04BEF001A001020302180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020383521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020401503 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339 | See source | Not stated by source | XG04BEF001A001020402180 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020483521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020501503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020583521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020601503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020683521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020701503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020783521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020801503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020883521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001020901503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001020983521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001021001503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021083521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001021101503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021183521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001021201503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021283521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001021301503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021383521 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129 | See source | Not stated by source | XG04BEF001A001021401503 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001021983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001022983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001023983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478 | See source | Not stated by source | XG04BEF001A001024583521 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001030104131 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001040104131 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001050104131 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953 | See source | Not stated by source | XG04BEF001A001060104131 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Loaded records: 4 filings and 3 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2502733 | Generic | 2025/07/30 | Not stated by source | CDE |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601846 | Generic | 2026/07/31 | Not stated by source | CDE |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601845 | Generic | 2026/07/31 | Not stated by source | CDE |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2600690 | Generic | 2026/03/21 | Not stated by source | CDE |
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601846 | Generic | 2026/07/31 | Not stated by source | CDE |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601845 | Generic | 2026/07/31 | Not stated by source | CDE |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2600690 | Generic | 2026/03/21 | Not stated by source | CDE |
Non-component matches: 9 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸伐地那非 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250000708 | I | Exact ingredient | 2025/07/16 | CDE |
| 盐酸伐地那非 · No verified English name | Shanghai He Quan Pharma Co., Ltd. romanized | Y20230001158 | A | Exact ingredient | 2025/07/29 | CDE |
| 盐酸伐地那非 · No verified English name | Yang Ling Ji Tai Pharma Co., Ltd. romanized | Y20230000021 | A | Exact ingredient | 2024/10/17 | CDE |
| 盐酸伐地那非 · No verified English name | Alembic Pharmaceuticals Limited | Y20210000075 | A | Exact ingredient | 2024/06/28 | CDE |
| 盐酸伐地那非 · No verified English name | Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20210000746 | A | Exact ingredient | 2023/09/27 | CDE |
| 盐酸伐地那非 · No verified English name | Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | Y20210000500 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸伐地那非 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20210000036 | A | Exact ingredient | 2025/01/11 | CDE |
| 盐酸伐地那非 · No verified English name | Jin Hong Pharma Co., Ltd., Jin Hong Pharma Co., Ltd. romanized | Y20200001095 | A | Exact ingredient | 2024/04/19 | CDE |
| 盐酸伐地那非 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20180001528 | A | Exact ingredient | 2024/02/07 | CDE |
| 盐酸伐地那非三水合物 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20180000752 | A | Salt-normalized ingredient | 2025/04/23 | CDE |
| 盐酸伐地那非三水合物 · No verified English name | Pharmaceutical Works POLPHARMA S.A. | Y20170001262 | I | Salt-normalized ingredient | — | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
CYHS2501279
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501278
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501726
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2025/05/14
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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