← FDA Drug Approvals (Drugs@FDA)
GABAPENTIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM · Approved 2010-12-17
Drug application
- FDA Application #
ANDA090858
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GABAPENTIN
- Generic name
- GABAPENTIN
- Active ingredients
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2010-12-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown