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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207018

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IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;150MG
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207018
Product Number: 001
Approval Date: Sep 19, 2017
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;300MG
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207018
Product Number: 002
Approval Date: Sep 19, 2017
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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