← FDA Drug Approvals (Drugs@FDA)
ROFLUMILAST
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2023-04-18
Drug application
- FDA Application #
ANDA212490- 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
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2023-04-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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