← FDA Drug Approvals (Drugs@FDA)
HYDROCORTISONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-05-02
Drug application
- FDA Application #
ANDA217881- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROCORTISONE
- Generic name
- HYDROCORTISONE
- Active ingredients
- HYDROCORTISONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVITIUM PHARMA
- Manufacturer
- ANI Pharmaceuticals, Inc.
- First approval
- 2025-05-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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