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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 210302


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NDA 210302 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic, Apotex, Macleods Pharms Ltd, Mylan, Prinston Inc, Zydus Lifesciences, Apotex Inc, and Dr Reddys Labs Ltd, and is included in thirteen NDAs. It is available from six 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. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 210302
Tradename:CANDESARTAN CILEXETIL
Applicant:Alembic
Ingredient:candesartan cilexetil
Patents:0
Pharmacology for NDA: 210302
Suppliers and Packaging for NDA: 210302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 210302 ANDA Alembic Pharmaceuticals Limited 46708-341 46708-341-30 30 TABLET in 1 BOTTLE (46708-341-30)
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 210302 ANDA Alembic Pharmaceuticals Limited 46708-341 46708-341-90 90 TABLET in 1 BOTTLE (46708-341-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Dec 4, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 4, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Dec 4, 2018TE:ABRLD:No

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