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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212106


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NDA 212106 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Casi Pharms Inc, Chartwell Rx, Cipla, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Teva Pharms Usa, Vitruvias, 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 212106
Tradename:ENTECAVIR
Applicant:Vitruvias
Ingredient:entecavir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212106
Suppliers and Packaging for NDA: 212106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 212106 ANDA Florida Pharmaceutical Products, LLC 71921-194 71921-194-33 30 TABLET in 1 BOTTLE (71921-194-33)
ENTECAVIR entecavir TABLET;ORAL 212106 ANDA Florida Pharmaceutical Products, LLC 71921-195 71921-195-33 30 TABLET in 1 BOTTLE (71921-195-33)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 10, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 10, 2020TE:ABRLD:No

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