← FDA Drug Approvals (Drugs@FDA)
LAMOTRIGINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2015-10-27
Drug application
- FDA Application #
ANDA204158
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LAMOTRIGINE
- Generic name
- LAMOTRIGINE
- Active ingredients
- LAMOTRIGINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PH HEALTH
- Manufacturer
- Par Health USA, LLC
- First approval
- 2015-10-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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