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Last Updated: November 24, 2024

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.
Summary for 020838
Tradename:ATACAND
Applicant:Ani Pharms
Ingredient:candesartan cilexetil
Patents:0
Pharmacology for NDA: 020838
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:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jun 4, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jun 4, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Jun 4, 1998TE:ABRLD: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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