Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090351

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IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;150MG
Marketing Status: Prescription

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: AB
Application Number: A090351
Product Number: 001
Approval Date: Oct 15, 2012
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;300MG
Marketing Status: Prescription

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: AB
Application Number: A090351
Product Number: 002
Approval Date: Oct 15, 2012
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
25MG;300MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090351
Product Number: 003
Approval Date: Jun 8, 2017
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information