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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210011


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NDA 210011 describes ALBENDAZOLE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Cipla Ltd, Dr Reddys, Edenbridge Pharms, MSN, Strides Pharma, and Zydus Pharms, and is included in nine NDAs. It is available from sixteen suppliers. Additional details are available on the ALBENDAZOLE profile page.

The generic ingredient in ALBENDAZOLE is albendazole. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the albendazole profile page.
Summary for 210011
Tradename:ALBENDAZOLE
Applicant:Strides Pharma
Ingredient:albendazole
Patents:0
Pharmacology for NDA: 210011
Mechanism of ActionCytochrome P450 1A Inducers
Medical Subject Heading (MeSH) Categories for 210011
Suppliers and Packaging for NDA: 210011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBENDAZOLE albendazole TABLET;ORAL 210011 ANDA Camber Pharmaceuticals 31722-935 31722-935-02 2 TABLET, FILM COATED in 1 BOTTLE (31722-935-02)
ALBENDAZOLE albendazole TABLET;ORAL 210011 ANDA Camber Pharmaceuticals 31722-935 31722-935-28 28 TABLET, FILM COATED in 1 BOTTLE (31722-935-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 7, 2018TE:ABRLD:No

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