Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204100

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CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE)
16MG;12.5MG
Marketing Status: Prescription

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204100
Product Number: 001
Approval Date: Feb 27, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE)
32MG;12.5MG
Marketing Status: Prescription

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204100
Product Number: 002
Approval Date: Feb 27, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE)
32MG;25MG
Marketing Status: Prescription

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204100
Product Number: 003
Approval Date: Feb 27, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information