← FDA Drug Approvals (Drugs@FDA)
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PIRAMAL · Approved 2025-05-14
Drug application
- FDA Application #
ANDA210718- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Generic name
- OLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE
- Active ingredients
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PIRAMAL
- Manufacturer
- Slate Run Pharmaceuticals, LLC
- First approval
- 2025-05-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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