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OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-07-18

Drug application

FDA Application #
ANDA207088
Application type
Abbreviated New Drug Application (Generic)
Brand name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Generic name
OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE
Active ingredients
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
MACLEODS PHARMS LTD
Manufacturer
Macleods Pharmaceuticals Limited
First approval
2025-07-18

Source

Authoritative
Drugs@FDA application overview
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