← FDA Drug Approvals (Drugs@FDA)
ROFLUMILAST
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TORRENT · Approved 2018-08-06
Drug application
- FDA Application #
ANDA208272- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ROFLUMILAST
- Generic name
- Roflumilast
- Active ingredients
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- TORRENT
- First approval
- 2018-08-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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