approval · primary record
ISONIAZID
2 approval events · latest 2025-12-05
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-12-05 |
| Approval events | 2 |
| Brand | RIFATER |
| Sponsor | SANOFI AVENTIS US |
| Route | ORAL |
Approval history
2 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 |
|---|---|---|---|---|---|
| 2025-12-05 | FDA | NDA | RIFATER | SANOFI AVENTIS US | ORAL |
| 2025-02-05 | FDA | NDA | NYDRAZID | SANDOZ | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:03.379Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:isoniazid
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Isoniazid · compound