Mylan Laboratories Limited
Check drug filings and source records for this company-name string.
Listed by the company name as recorded in the source, without merging affiliated entities.
Page reference 65aa0b2388
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/11 06:42.
Drug filings
16 acceptance records as first applicant, grouped into 12 source drug names. Source data as of 2026/11/11 06:42.
Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.
No verified English name 1 records · Latest accepted 2026/02/25
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2600042 | Not stated by source | 2026/02/25 | Mylan Laboratories Limited; MYLAN IRELAND LTD; Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2023/11/10
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2300260 | Not stated by source | 2023/11/10 | Mylan Laboratories Limited; Mylan Ireland Limited; Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Mycophenolate Mofetil Capsules 1 records · Latest accepted 2023/09/20
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300118 | Import | 2023/09/20 | Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd. | CDE ↗ |
Mirtazapine Tablets 2 records · Latest accepted 2023/09/20
Import · 2
Mycophenolate Sodium Enteric-coated Tablets 1 records · Latest accepted 2023/09/06
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300115 | Import | 2023/09/06 | Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd. | CDE ↗ |
Levothyroxine Sodium Tablets 2 records · Latest accepted 2023/06/21
Import · 2
Hydroxychloroquine Sulfate Tablets 1 records · Latest accepted 2023/02/24
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300032 | Import | 2023/02/24 | Mylan Laboratories Limited | CDE ↗ |
Desloratadine Tablets 1 records · Latest accepted 2023/02/14
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300021 | Import | 2023/02/14 | Mylan Laboratories Limited | CDE ↗ |
Pantoprazole Enteric-Coated Tablets 2 records · Latest accepted 2023/01/12
Import · 2
Lanthanum Carbonate Chewable Tablets 1 records · Latest accepted 2021/12/28
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2101062 | Import | 2021/12/28 | Mylan Laboratories Limited | CDE ↗ |
No verified English name 2 records · Latest accepted 2021/12/22
Not stated by source · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2100726 | Not stated by source | 2021/12/22 | Mylan Laboratories Limited; Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | CDE ↗ |
| JTH2100652 | Not stated by source | 2021/09/17 | Mylan Laboratories Limited; Hebei Long Hai Pharma Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2021/02/02
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2100036 | Not stated by source | 2021/02/02 | Mylan Laboratories Limited; Da Lian Ke Xiang Technology Kai Fa Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
0 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.
This source was last successfully updated at 2026/11/10 18:31; current coverage may be incomplete.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
Under review
0 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/11 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
Catalogue holder records
7 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Mycophenolate Mofetil Capsules | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250098 | 2025/08/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Mirtazapine Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250044 | 2025/04/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Mycophenolate Sodium Enteric-coated Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250028 | 2025/03/11 | Not stated by source | CDE ↗ |
| Desloratadine Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250011 | 2025/01/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pantoprazole Enteric-Coated Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20240099 | 2024/09/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pantoprazole Enteric-Coated Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20240100 | 2024/09/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Lanthanum Carbonate Chewable Tablets | Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20230116 | 2023/10/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.
API registrations
5 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| No verified English name | Mylan Laboratories Limited | Y20220000753 | I | 2023/01/11 | CDE ↗ |
| No verified English name | Mylan Laboratories Limited | Y20190021221 | A | 2022/10/14 | CDE ↗ |
| No verified English name | Mylan Laboratories Limited | Y20190000954 | I | 2020/01/10 | CDE ↗ |
| No verified English name | Mylan Laboratories Limited | Y20190000955 | I | 2020/01/10 | CDE ↗ |
| No verified English name | Mylan Laboratories Limited | Y20190000952 | I | 2020/01/03 | CDE ↗ |
Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.
Co-applicant records
24 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/11 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| No verified English name | JXHS2300120 | Import | 2023/12/12 | Mylan Ireland Limited; Mylan Laboratories Limited; Shenyang Hongqi Pharmaceutical Co. Ltd. | CDE ↗ |
| No verified English name | JTH2300258 | Not stated by source | 2023/11/09 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2300160 | Not stated by source | 2023/07/04 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2300123 | Not stated by source | 2023/05/12 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2300027 | Not stated by source | 2023/02/02 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2300010 | Not stated by source | 2023/01/11 | Mylan Laboratories Limited (Unit 1); Mylan Laboratories Limited; Qi Lu Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2200188 | Not stated by source | 2022/09/14 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2200137 | Not stated by source | 2022/07/19 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2200075 | Not stated by source | 2022/04/15 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Bosentan Tablets | JYHS2200026 | Import | 2022/03/15 | Mylan S.p.A.; Mylan Laboratories Limited; Tianjin Happy Life Technology Co. Ltd. | CDE ↗ |
| Bosentan Tablets | JYHS2200025 | Import | 2022/03/15 | Mylan S.p.A.; Mylan Laboratories Limited; Tianjin Happy Life Technology Co. Ltd. | CDE ↗ |
| No verified English name | JTH2200030 | Not stated by source | 2022/02/18 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2200013 | Not stated by source | 2022/01/25 | Mylan Laboratories Limited (Unit-7); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2200004 | Not stated by source | 2022/01/07 | Mylan Laboratories Limited(Unit-7); Mylan Laboratories Limited; Chongqing Yao You Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100694 | Not stated by source | 2021/11/23 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Darunavir Tablets | JYHS2101044 | Import | 2021/09/26 | Mylan S.A.S.; Mylan Laboratories Limited | CDE ↗ |
| No verified English name | JTH2100651 | Not stated by source | 2021/09/17 | Aurore Pharmaceutical Private Limited; Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100648 | Not stated by source | 2021/09/13 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hainan Sai Li Ke Pharma Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100615 | Not stated by source | 2021/08/11 | Aurore Pharmaceutical Private Limited; Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100587 | Not stated by source | 2021/08/03 | Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hainan Sai Li Ke Pharma Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100576 | Not stated by source | 2021/07/20 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100531 | Not stated by source | 2021/05/18 | Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100530 | Not stated by source | 2021/05/18 | Mylan Laboratories Limited (Unit-7); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2100028 | Not stated by source | 2021/02/05 | Mylan Laboratories Limited (Unit-11); Mylan Laboratories Limited; Xin Ling Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized | CDE ↗ |
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/11 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/11 06:38
- Full API register
- Last successful update: 2026/11/11 06:40
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete
First index-page publication dates: — to —; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
Listed by the company name as recorded in the source, without merging affiliated entities.
This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.
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.
Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.