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Details for New Drug Application (NDA): 021093

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NDA 021093 describes ATACAND HCT, which is a drug marketed by Astrazeneca 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. Seven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

Summary for NDA: 021093

Tradename:
ATACAND HCT
Applicant:
Astrazeneca
Ingredient:
candesartan cilexetil; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021093

Ingredient-typeThiazides
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 0186-0162 0186-0162-54 90 TABLET in 1 BOTTLE (0186-0162-54)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG;12.5MG
Approval Date:Sep 5, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;12.5MG
Approval Date:Sep 5, 2000TE:ABRLD:No

Summary for product number 003

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

Expired Orange Book Patents for NDA: 021093

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 20005,705,517*PED► subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-003May 16, 20085,196,444*PED► subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 20005,196,444*PED► subscribe
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