Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021093

Expand all

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English