Details for New Drug Application (NDA): 020838
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NDA 020838 describes ATACAND, which is a drug marketed by Ani Pharms and is included in two NDAs. It is available from five suppliers. Additional details are available on the ATACAND profile page.
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.
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 | 020838-002 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-004 | 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 | 020838-001 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-002 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-004 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-004 | Jun 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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