approval · primary record
Unspecified
6 approval events · latest 2026-08-17
| Agency | FDA |
|---|---|
| Submission type | NDA, BLA |
| Latest action | 2026-08-17 |
| Approval events | 6 |
| Brand | — |
| Sponsor | SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD |
| Route | Not stated |
Approval history
6 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-08-17 | FDA | NDA | — | SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD | — |
| 2025-10-15 | FDA | BLA | — | MERCK SHARP AND DOHME LLC | — |
| 2025-05-20 | FDA | NDA | — | AUSON PHARM | — |
| 2025-03-13 | FDA | NDA | — | CIPLA LIMITED | — |
| 2025-01-17 | FDA | NDA | — | COLUMBIA THERAPEUTICS INC | — |
| 2024-12-20 | FDA | NDA | — | CIPLA USA | — |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:27:46.266Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:unspecified
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Unspecified · compound