← FDA Drug Approvals (Drugs@FDA)
SERTRALINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HERITAGE · Approved 2006-08-11
Drug application
- FDA Application #
ANDA076465- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SERTRALINE HYDROCHLORIDE
- Generic name
- SERTRALINE
- Active ingredients
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HERITAGE
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- First approval
- 2006-08-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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