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Vardenafil Hydrochloride Tablets

As 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

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Zhejiang Nord Pharmaceutical Co., LtdZhejiang Nord Pharmaceutical Co., Ltd国药准字H202654782026/08/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Lu Yin Pharma Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202648002026/06/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Lu Yin Pharma Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202647992026/06/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Nord Pharmaceutical Co., LtdZhejiang Nord Pharmaceutical Co., Ltd国药准字H202637152026/03/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Hui Ren Pharma Co., Ltd. romanizedJiangxi Hui Ren Pharma Co., Ltd. romanized国药准字H202564142025/12/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Hui Ren Pharma Co., Ltd. romanizedJiangxi Hui Ren Pharma Co., Ltd. romanized国药准字H202564152025/12/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202549532025/07/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedGuangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H202541732025/05/13See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202541302025/05/13See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202541292025/05/13See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanizedNanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H202495722024/12/01See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanizedGuo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H202494312024/11/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanizedZhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized国药准字H202490292024/10/09See sourceGeneric approved under the new chemical-drug registration classificationCDE
Anhui Pioneer Pharmaceutical Co., LtdAnhui Pioneer Pharmaceutical Co., Ltd国药准字H202447922024/09/03See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanizedShandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H202431232024/01/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanizedShandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H202431242024/01/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yangtze River Pharmaceutical Group Co., LtdYangtze River Pharmaceutical Group Co., Ltd国药准字H202337682023/06/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangxi Qiang Shou Pharma Group Co., Ltd. romanizedGuangxi Qiang Shou Pharma Group Co., Ltd. romanized国药准字H202336902023/06/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202033392020/07/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202033382020/07/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Bayer AGBayer AGH20140495;H201404972004/08/0520mgImported originator drugCDE

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.

NHSA drug codes

Loaded records: 16 distinct approval numbers and 12 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H20254173See sourceNot stated by sourceXG04BEF001A001010100475NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010101503NHSA
Yangtze River Pharmaceutical Group Co., Ltd国药准字H20233768See sourceNot stated by sourceXG04BEF001A001010101749NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010102180NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001010104131NHSA
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20244792See sourceNot stated by sourceXG04BEF001A001010104339NHSA
Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized国药准字H20249029See sourceNot stated by sourceXG04BEF001A001010104578NHSA
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H20249431See sourceNot stated by sourceXG04BEF001A001010104873NHSA
Guangxi Qiang Shou Pharma Group Co., Ltd. romanized国药准字H20233690See sourceNot stated by sourceXG04BEF001A001010105134NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010183087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010183521NHSA
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized国药准字H20243123See sourceNot stated by sourceXG04BEF001A001010183946NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010201503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010202180NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001010204131NHSA
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20244792See sourceNot stated by sourceXG04BEF001A001010204339NHSA
Guangxi Qiang Shou Pharma Group Co., Ltd. romanized国药准字H20233690See sourceNot stated by sourceXG04BEF001A001010205134NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010283087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010283521NHSA
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized国药准字H20243123See sourceNot stated by sourceXG04BEF001A001010283946NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010301503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010302180NHSA
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20244792See sourceNot stated by sourceXG04BEF001A001010304339NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010383087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010383521NHSA
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized国药准字H20243123See sourceNot stated by sourceXG04BEF001A001010383946NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010401503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010402180NHSA
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20244792See sourceNot stated by sourceXG04BEF001A001010404339NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010483087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010483521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010501503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010502180NHSA
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20244792See sourceNot stated by sourceXG04BEF001A001010504339NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010583087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010583521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010601503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010602180NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010683087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010683521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010701503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010702180NHSA
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249572See sourceNot stated by sourceXG04BEF001A001010783087NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010783521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010801503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010802180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010883521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001010901503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001010902180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001010983521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011001503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203338See sourceNot stated by sourceXG04BEF001A001011002180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011083521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011101503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011183521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011201503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011283521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011301503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011383521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011401503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011483521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011501503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011583521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254130See sourceNot stated by sourceXG04BEF001A001011601503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001011983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001012983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20263715See sourceNot stated by sourceXG04BEF001A001013583521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020101503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203339See sourceNot stated by sourceXG04BEF001A001020102180NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001020104131NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020183521NHSA
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized国药准字H20243124See sourceNot stated by sourceXG04BEF001A001020183946NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020201503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203339See sourceNot stated by sourceXG04BEF001A001020202180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020283521NHSA
Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized国药准字H20243124See sourceNot stated by sourceXG04BEF001A001020283946NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020301503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203339See sourceNot stated by sourceXG04BEF001A001020302180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020383521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020401503NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203339See sourceNot stated by sourceXG04BEF001A001020402180NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020483521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020501503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020583521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020601503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020683521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020701503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020783521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020801503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020883521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001020901503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001020983521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001021001503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021083521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001021101503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021183521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001021201503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021283521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001021301503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021383521NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20254129See sourceNot stated by sourceXG04BEF001A001021401503NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001021983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001022983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001023983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20265478See sourceNot stated by sourceXG04BEF001A001024583521NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001030104131NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001040104131NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001050104131NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H20254953See sourceNot stated by sourceXG04BEF001A001060104131NHSA

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.

Current under-review applications

Loaded records: 4 filings and 3 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.CYHS2502733Generic2025/07/30Not stated by sourceCDE
Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCYHS2601846Generic2026/07/31Not stated by sourceCDE
Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCYHS2601845Generic2026/07/31Not stated by sourceCDE
Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanizedCYHS2600690Generic2026/03/21Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCYHS2601846Generic2026/07/31Not stated by sourceCDE
Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCYHS2601845Generic2026/07/31Not stated by sourceCDE
Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanizedCYHS2600690Generic2026/03/21Not stated by sourceCDE
API registrations

Non-component matches: 9 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸伐地那非 · No verified English nameShandong Ji Kun Biopharmaceutical Co., Ltd. romanizedY20250000708IExact ingredient2025/07/16CDE
盐酸伐地那非 · No verified English nameShanghai He Quan Pharma Co., Ltd. romanizedY20230001158AExact ingredient2025/07/29CDE
盐酸伐地那非 · No verified English nameYang Ling Ji Tai Pharma Co., Ltd. romanizedY20230000021AExact ingredient2024/10/17CDE
盐酸伐地那非 · No verified English nameAlembic Pharmaceuticals LimitedY20210000075AExact ingredient2024/06/28CDE
盐酸伐地那非 · No verified English nameChangzhou Pharmaceutical Factory Co., Ltd. romanizedY20210000746AExact ingredient2023/09/27CDE
盐酸伐地那非 · No verified English nameGuangxi Qiang Shou Pharma Group Co., Ltd. romanizedY20210000500AExact ingredient2024/01/17CDE
盐酸伐地那非 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20210000036AExact ingredient2025/01/11CDE
盐酸伐地那非 · No verified English nameJin Hong Pharma Co., Ltd., Jin Hong Pharma Co., Ltd. romanizedY20200001095AExact ingredient2024/04/19CDE
盐酸伐地那非 · No verified English nameShandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY20180001528AExact ingredient2024/02/07CDE
盐酸伐地那非三水合物 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20180000752ASalt-normalized ingredient2025/04/23CDE
盐酸伐地那非三水合物 · No verified English namePharmaceutical Works POLPHARMA S.A.Y20170001262ISalt-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.

What changed recently?

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.

  1. 2026/11/07No longer listed under review

    Jiangxi Shimei Pharmaceutical Co., Ltd

    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 ↗
  2. 2026/11/07No longer listed under review

    Jiangxi Shimei Pharmaceutical Co., Ltd

    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 ↗
  3. 2026/10/27No longer listed under review

    Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized

    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 ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

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.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

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.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

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.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

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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