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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212201


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NDA 212201 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Chartwell Rx, Cipla, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in seventeen NDAs. It is available from fifteen suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 212201
Tradename:ENTECAVIR
Applicant:Yaopharma Co Ltd
Ingredient:entecavir
Patents:0
Pharmacology for NDA: 212201
Suppliers and Packaging for NDA: 212201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 212201 ANDA Yaopharma Co., Ltd. 50771-013 50771-013-01 30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01)
ENTECAVIR entecavir TABLET;ORAL 212201 ANDA Yaopharma Co., Ltd. 50771-013 50771-013-02 90 TABLET, FILM COATED in 1 BOTTLE (50771-013-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.5MG
Approval Date:Nov 4, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Nov 4, 2019TE:RLD:No

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