← FDA Drug Approvals (Drugs@FDA)
FLUDROCORTISONE ACETATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2022-05-31
Drug application
- FDA Application #
ANDA215279- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLUDROCORTISONE ACETATE
- Generic name
- FLUDROCORTISONE ACETATE
- Active ingredients
- FLUDROCORTISONE ACETATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVITIUM PHARMA
- Manufacturer
- Novitium Pharma LLC
- First approval
- 2022-05-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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