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OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2025-11-24

Drug application

FDA Application #
ANDA207437
Application type
Abbreviated New Drug Application (Generic)
Brand name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Generic name
OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE
Active ingredients
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
MICRO LABS
Manufacturer
Micro Labs Limited
First approval
2025-11-24

Source

Authoritative
Drugs@FDA application overview
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