← FDA Drug Approvals (Drugs@FDA)
DILANTIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: VIATRIS · Approved 1976-08-27
Drug application
- FDA Application #
ANDA084349
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DILANTIN
- Generic name
- EXTENDED PHENYTOIN SODIUM
- Active ingredients
- PHENYTOIN SODIUM
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- VIATRIS
- Manufacturer
- Viatris Specialty LLC
- First approval
- 1976-08-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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