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Details for New Drug Application (NDA): 206217

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NDA 206217 describes ENTECAVIR, which is a drug marketed by Aurobindo Pharma Ltd, Teva Pharms Usa, Hetero Labs Ltd V, and Amneal Pharms, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the entecavir profile page.

Summary for NDA: 206217

Tradename:
ENTECAVIR
Applicant:
Aurobindo Pharma Ltd
Ingredient:
entecavir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 206217

Suppliers and Packaging for NDA: 206217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR
entecavir
TABLET;ORAL 206217 ANDA American Health Packaging 60687-216 60687-216-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) > 1 TABLET in 1 BLISTER PACK (60687-216-95)
ENTECAVIR
entecavir
TABLET;ORAL 206217 ANDA Aurobindo Pharma Limited 65862-841 65862-841-30 1 BOTTLE in 1 CARTON (65862-841-30) > 30 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 26, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 26, 2015TE:ABRLD:No


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