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SERTRALINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INVAGEN PHARMS · Approved 2007-02-06
Drug application
- FDA Application #
ANDA077397- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SERTRALINE HYDROCHLORIDE
- Generic name
- SERTRALINE HYDROCHLORIDE
- Active ingredients
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- INVAGEN PHARMS
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- First approval
- 2007-02-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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