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Generated: November 21, 2017

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Details for New Drug Application (NDA): 202079

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NDA 202079 describes CANDESARTAN CILEXETIL, which is a drug marketed by Sandoz, Macleods Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Zydus Pharms Usa Inc, Mylan Pharms Inc, and Dr Reddys Labs Ltd, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the CANDESARTAN CILEXETIL profile page.

The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

Summary for 202079

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202079

Suppliers and Packaging for NDA: 202079

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
candesartan cilexetil
TABLET;ORAL 202079 ANDA Apotex Corp. 60505-3618 60505-3618-3 30 TABLET in 1 BOTTLE (60505-3618-3)
candesartan cilexetil
TABLET;ORAL 202079 ANDA Apotex Corp. 60505-3619 60505-3619-3 30 TABLET in 1 BOTTLE (60505-3619-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jan 10, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jan 10, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Jan 10, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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