← FDA Drug Approvals (Drugs@FDA)
AMLODIPINE BESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA · Approved 2007-07-09
Drug application
- FDA Application #
ANDA078226- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMLODIPINE BESYLATE
- Generic name
- AMLODIPINE BESYLATE
- Active ingredients
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZYDUS PHARMS USA
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- First approval
- 2007-07-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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