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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021093


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NDA 021093 describes ATACAND HCT, which is a drug marketed by Ani Pharms Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the ATACAND HCT profile page.

The generic ingredient in ATACAND HCT is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Nine 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 Inc
Ingredient:candesartan cilexetil; hydrochlorothiazide
Patents:0
Pharmacology for NDA: 021093
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased 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 AstraZeneca Pharmaceuticals LP 0186-0322 0186-0322-54 90 TABLET in 1 BOTTLE (0186-0322-54)
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)
Paragraph IV (Patent) Challenges for 021093
Tradename Dosage Ingredient NDA Submissiondate
ATACAND HCT TABLET;ORAL candesartan cilexetil; hydrochlorothiazide 021093 2009-03-06
ATACAND HCT TABLET;ORAL candesartan cilexetil; hydrochlorothiazide 021093 2008-06-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG;12.5MG
Approval Date:Sep 5, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;12.5MG
Approval Date:Sep 5, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;25MG
Approval Date:May 16, 2008TE:ABRLD:Yes

Expired US Patents for NDA 021093

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Express Scripts
Moodys

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