← FDA Drug Approvals (Drugs@FDA)
VIGABATRIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL · Approved 2021-09-23
Drug application
- FDA Application #
ANDA215109
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- VIGABATRIN
- Generic name
- VIGABATRIN
- Active ingredients
- VIGABATRIN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- DEXCEL
- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- First approval
- 2021-09-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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