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FDA source evidence

ANDA207037

FDA application evidence

ANDA207037

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Application summary

Application number
ANDA207037
Sponsor
ALKEM LABS LTD
Product / brand name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Active ingredients
HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
Submission type
SUPPL
Submission status
AP
Submission date
20260423
Review priority
STANDARD
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
TE code
AB
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