← FDA Drug Approvals (Drugs@FDA)
TOFACITINIB CITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2025-08-19
Drug application
- FDA Application #
ANDA219542- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TOFACITINIB CITRATE
- Generic name
- Tofacitinib Citrate
- Active ingredients
- TOFACITINIB CITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AJANTA PHARMA LTD
- First approval
- 2025-08-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown