← FDA Drug Approvals (Drugs@FDA)
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-01-07
Drug application
- FDA Application #
ANDA207299- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
- Generic name
- AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
- Active ingredients
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MACLEODS PHARMS LTD
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2025-01-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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