← FDA Drug Approvals (Drugs@FDA)
TOFACITINIB CITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL · Approved 2024-12-16
Drug application
- FDA Application #
ANDA218668- 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
- None (Tentative Approval)
- Sponsor
- DEXCEL
- First approval
- 2024-12-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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