Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021093

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

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: ATACAND HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG;12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021093
Product Number: 001
Approval Date: Sep 5, 2000
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: ATACAND HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG;12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021093
Product Number: 002
Approval Date: Sep 5, 2000
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Proprietary Name: ATACAND HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG;25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021093
Product Number: 003
Approval Date: May 16, 2008
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information