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Candesartan cilexetil; hydrochlorothiazide - Generic Drug Details

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Candesartan cilexetil; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Macleods Pharms Ltd, Mylan Labs, Dr Reddys Labs Ltd, Apotex Inc, and Astrazeneca, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for candesartan cilexetil; hydrochlorothiazide. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: candesartan cilexetil; hydrochlorothiazide

Tradenames:2
Patents:0
Applicants:5
NDAs:5
Drug Master File Entries: see list22
Suppliers / Packaging: see list6
Formulation / Manufacturing:see details

Pharmacology for Ingredient: candesartan cilexetil; hydrochlorothiazide

Tentative approvals for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL16MG; 12.5MG
<disabled><disabled>TABLET; ORAL32MG; 12.5MG
<disabled><disabled>TABLET; ORAL32MG; 25MG

Clinical Trials for: candesartan cilexetil; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 2000RXNo<disabled><disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 2000RXNo<disabled><disabled>
Apotex Inc
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL202884-001Dec 4, 2012RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: candesartan cilexetil; hydrochlorothiazide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 20005,958,961<disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 20005,958,961<disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 20005,705,517*PED<disabled>
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