Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020838

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NDA 020838 describes ATACAND, which is a drug marketed by Ani Pharms Inc and is included in two NDAs. It is available from four 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. Eight 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 Inc
Ingredient:candesartan cilexetil
Patents:0
Formulation / Manufacturing:see details
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 AstraZeneca Pharmaceuticals LP 0186-0004 0186-0004-31 30 TABLET in 1 BOTTLE (0186-0004-31)
ATACAND candesartan cilexetil TABLET;ORAL 020838 NDA AstraZeneca Pharmaceuticals LP 0186-0008 0186-0008-31 30 TABLET in 1 BOTTLE (0186-0008-31)
Paragraph IV (Patent) Challenges for 020838
Tradename Dosage Ingredient NDA Submissiondate
ATACAND TABLET;ORAL candesartan cilexetil 020838 2006-12-22

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 Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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