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Candesartan cilexetil - Generic Drug Details

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

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

Summary for Generic Name: candesartan cilexetil

Tradenames:4
Patents:0
Applicants:6
NDAs:8
Drug Master File Entries: see list22
Suppliers / Packaging: see list8
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: candesartan cilexetil

Tentative approvals for CANDESARTAN CILEXETIL

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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
CANDESARTAN CILEXETIL
candesartan cilexetil
TABLET;ORAL078702-002May 3, 2013RXNo<disabled><disabled>
Macleods Pharms Ltd
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL204100-002Feb 27, 2015RXNo<disabled><disabled>
Astrazeneca
ATACAND
candesartan cilexetil
TABLET;ORAL020838-004Jun 4, 1998RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: candesartan cilexetil

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ATACAND
candesartan cilexetil
TABLET;ORAL020838-002Jun 4, 19985,705,517*PED<disabled>
Astrazeneca
ATACAND
candesartan cilexetil
TABLET;ORAL020838-003Jun 4, 19985,534,534*PED<disabled>
Astrazeneca
ATACAND
candesartan cilexetil
TABLET;ORAL020838-002Jun 4, 19985,508,297<disabled>
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