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Sign in to subscribeAs of 13 November 2026, for Tranexamic Acid Tablets, 9 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 10 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as LYSTEDA (NDA 022430, J MOLNER HOLDINGS INC).
Last 90 days: Accepted: 3 applicationsNo longer listed under review: 2 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 |
|---|---|---|---|---|---|---|
| LYSTEDA | J MOLNER HOLDINGS INC | NDA 022430 · Product no. 001 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2009/11/13 |
| CYKLOKAPRON | PHARMACIA AND UPJOHN CO | NDA 019280 · Product no. 001 | TABLET | ORAL | DISCONTINUED | 1986/12/30 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| CYKLOKAPRON | PFIZER INC | NDA 019281 · Product no. 001 | INJECTABLE | INJECTION | HUMAN PRESCRIPTION DRUG | 1986/12/30 |
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: 10 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 8 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 |
|---|---|---|---|---|---|---|
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20264299 | 2026/05/12 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 国药准字H20264055 | 2026/04/21 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263816 | 2026/03/31 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20263466 | 2026/02/25 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H20263108 | 2026/01/14 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | Beijing Bei Lu Pharma Co., Ltd. romanized | 国药准字H20256156 | 2025/12/03 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H20255025 | 2025/07/29 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 2023/12/13 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H43020564 | 2023/10/30 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Di Yi San Gong Zhu Shi Hui She romanized | CMIC CMO CO.,LTD.Shizuoka Plant | H20160282 | 2000/10/07 | 0.5g | 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: 13 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H20256156 | 0.5g | Category B | XB02AAA172A001010100014 | NHSA |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H31020040 | 0.25g | Category B | XB02AAA172A001010100804 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20264299 | 0.25g | Category B | XB02AAA172A001010102013 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20253413 | 0.5g | Category B | XB02AAA172A001010102763 | NHSA |
| Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized | 国药准字H41021481 | 0.125g | Category B | XB02AAA172A001010103085 | NHSA |
| Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized | 国药准字H41025628 | 0.125g | Category B | XB02AAA172A001010103250 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010104223 | NHSA |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H20255025 | 0.25g | Category B | XB02AAA172A001010104489 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H43020564 | 0.25g | Category B | XB02AAA172A001010104917 | NHSA |
| Guo Yao Group Tong Ji Tang (Guizhou) Pharmaceutical Co., Ltd. romanized | 国药准字H52020898 | 0.25g | Category B | XB02AAA172A001010105535 | NHSA |
| DAIICHI SANKYO CO., LTD. | 国药准字HJ20160282 | 0.5g | Category B | XB02AAA172A001010179008 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20263466 | 0.5g | Category B | XB02AAA172A001010183549 | NHSA |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H20256156 | 0.5g | Category B | XB02AAA172A001010200014 | NHSA |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H31020040 | 0.25g | Category B | XB02AAA172A001010200804 | NHSA |
| Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized | 国药准字H41021481 | 0.125g | Category B | XB02AAA172A001010203085 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010204223 | NHSA |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H20255025 | 0.25g | Category B | XB02AAA172A001010204489 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H43020564 | 0.25g | Category B | XB02AAA172A001010204917 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20263466 | 0.5g | Category B | XB02AAA172A001010283549 | NHSA |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H20256156 | 0.5g | Category B | XB02AAA172A001010300014 | NHSA |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H31020040 | 0.25g | Category B | XB02AAA172A001010300804 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010304223 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H43020564 | 0.25g | Category B | XB02AAA172A001010304917 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20263466 | 0.5g | Category B | XB02AAA172A001010383549 | NHSA |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H20256156 | 0.5g | Category B | XB02AAA172A001010400014 | NHSA |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H31020040 | 0.25g | Category B | XB02AAA172A001010400804 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010404223 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H43020564 | 0.25g | Category B | XB02AAA172A001010404917 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20263466 | 0.5g | Category B | XB02AAA172A001010483549 | NHSA |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H31020040 | 0.25g | Category B | XB02AAA172A001010500804 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010504223 | NHSA |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H20234646 | 0.25g | Category B | XB02AAA172A001010604223 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263816 | 0.25g | Category B | XB02AAA172A001020102763 | 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: 9 filings and 7 distinct first applicants.
Generic 9
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600960 | Generic | 2026/04/24 | Not stated by source | CDE |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602371 | Generic | 2026/09/21 | Not stated by source | CDE |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602370 | Generic | 2026/09/21 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602439 | Generic | 2026/09/30 | Not stated by source | CDE |
| Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601889 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2601512 | Generic | 2026/06/26 | Not stated by source | CDE |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2504106 | Generic | 2025/11/28 | Not stated by source | CDE |
| Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2503947 | Generic | 2025/11/13 | Not stated by source | CDE |
| Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2503946 | Generic | 2025/11/13 | Not stated by source | CDE |
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600960 | Generic | 2026/04/24 | Not stated by source | CDE |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602371 | Generic | 2026/09/21 | Not stated by source | CDE |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602370 | Generic | 2026/09/21 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602439 | Generic | 2026/09/30 | Not stated by source | CDE |
| Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601889 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2601512 | Generic | 2026/06/26 | Not stated by source | CDE |
Non-component matches: 15 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 氨甲环酸 · No verified English name | Jiangsu Tian He Pharmaceutical Co., Ltd. romanized | Y20260000642 | I | Exact ingredient | 2026/08/03 | CDE |
| 氨甲环酸 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20250001276 | I | Exact ingredient | 2025/12/16 | CDE |
| 氨甲环酸 · No verified English name | Zhejiang Zhu Zi Pharmaceutical Co., Ltd. romanized | Y20250000943 | I | Exact ingredient | 2025/09/18 | CDE |
| 氨甲环酸 · No verified English name | Anhui Ding Wang Pharmaceuticals Co., Ltd. romanized | Y20250000688 | I | Exact ingredient | 2025/07/15 | CDE |
| 氨甲环酸 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20240001282 | A | Exact ingredient | 2026/02/09 | CDE |
| 氨甲环酸 · No verified English name | SHILPA PHARMA LIFESCIENCES LIMITED 100% EOU | Y20230000616 | I | Exact ingredient | 2023/09/12 | CDE |
| 氨甲环酸 · No verified English name | Ami lifesciences Pvt. Ltd. | Y20210000315 | A | Exact ingredient | 2026/09/06 | CDE |
| 氨甲环酸 · No verified English name | Hunan Sai Long Pharma Co., Ltd. romanized | Y20210000177 | A | Exact ingredient | 2026/05/08 | CDE |
| 氨甲环酸 · No verified English name | DAIICHI SANKYO CO.,LTD. | Y20190009106 | A | Exact ingredient | — | CDE |
| 氨甲环酸 · No verified English name | Xian Li Bang Pharmaceutical Co., Ltd. romanized | Y20190008931 | A | Exact ingredient | 2024/01/31 | CDE |
| 氨甲环酸 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190006868 | A | Exact ingredient | 2023/03/24 | CDE |
| 氨甲环酸 · No verified English name | Hubei Zhong Jia He Cheng Pharmaceutical Co., Ltd. romanized | Y20190006325 | A | Exact ingredient | 2026/04/15 | CDE |
| 氨甲环酸 · No verified English name | Changzhou Yin Sheng Pharma Co., Ltd. romanized | Y20190006181 | A | Exact ingredient | 2025/12/23 | CDE |
| 氨甲环酸 · No verified English name | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190004445 | A | Exact ingredient | 2024/09/11 | CDE |
| 氨甲环酸 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190003756 | A | Exact ingredient | — | CDE |
| 氨甲环酸 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190002895 | A | Exact ingredient | 2025/03/04 | CDE |
| 氨甲环酸 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002704 | A | Exact ingredient | — | CDE |
| 氨甲环酸 · No verified English name | Hainan Huluwa Pharmaceutical Group Co., Ltd. | Y20190002448 | A | Exact ingredient | 2024/07/16 | CDE |
| 氨甲环酸 · No verified English name | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20190001677 | A | Exact ingredient | 2025/03/12 | CDE |
| 氨甲环酸 · No verified English name | Yan Tai Wan Run Pharma Co., Ltd. romanized | Y20170000447 | A | Exact ingredient | 2024/01/12 | 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.
CYHS2502388
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2025/07/05
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2502387
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2025/07/05
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2602439
Fact date: 2026/09/30 · Site observation date: 2026/10/22
View source ↗CYHS2602371
Fact date: 2026/09/21 · Site observation date: 2026/10/21
View source ↗CYHS2602370
Fact date: 2026/09/21 · Site observation date: 2026/10/21
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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