Details for New Drug Application (NDA): 020838
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The generic ingredient in ATACAND 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 020838
Tradename: | ATACAND |
Applicant: | Ani Pharms |
Ingredient: | candesartan cilexetil |
Patents: | 0 |
Pharmacology for NDA: 020838
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 020838
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATACAND | candesartan cilexetil | TABLET;ORAL | 020838 | NDA AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 49884-658 | 49884-658-09 | 90 TABLET in 1 BOTTLE (49884-658-09) |
ATACAND | candesartan cilexetil | TABLET;ORAL | 020838 | NDA AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 49884-659 | 49884-659-09 | 90 TABLET in 1 BOTTLE (49884-659-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Jun 4, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Jun 4, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Jun 4, 1998 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020838
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-003 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-003 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-002 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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