Details for New Drug Application (NDA): 021093
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The generic ingredient in ATACAND HCT is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 021093
Tradename: | ATACAND HCT |
Applicant: | Ani Pharms |
Ingredient: | candesartan cilexetil; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 021093
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 021093
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093 | NDA | ANI Pharmaceuticals, Inc. | 62559-650 | 62559-650-90 | 90 TABLET in 1 BOTTLE (62559-650-90) |
ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093 | NDA | ANI Pharmaceuticals, Inc. | 62559-651 | 62559-651-90 | 90 TABLET in 1 BOTTLE (62559-651-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG;12.5MG | ||||
Approval Date: | Sep 5, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;12.5MG | ||||
Approval Date: | Sep 5, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;25MG | ||||
Approval Date: | May 16, 2008 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021093
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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