← FDA Drug Approvals (Drugs@FDA)
ROFLUMILAST
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN · Approved 2022-09-07
Drug application
- FDA Application #
ANDA208256- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ROFLUMILAST
- Generic name
- ROFLUMILAST
- Active ingredients
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MSN
- Manufacturer
- Novadoz Pharmaceuticals LLC
- First approval
- 2022-09-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown