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Serving 500+ biopharmaceutical companies globally:

McKesson
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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202122

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NDA 202122 describes ENTECAVIR, which is a drug marketed by Aurobindo Pharma Ltd, Teva Pharms Usa, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Amneal Pharms, Cipla Ltd, Sandoz Inc, and Par Pharm Inc, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the ENTECAVIR profile page.

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

Summary for NDA: 202122

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 202122

Suppliers and Packaging for NDA: 202122

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR
entecavir
TABLET;ORAL 202122 ANDA Teva Pharmaceuticals USA, Inc. 0093-5786 0093-5786-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5786-56)
ENTECAVIR
entecavir
TABLET;ORAL 202122 ANDA Teva Pharmaceuticals USA, Inc. 0093-5786 0093-5786-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-5786-98)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 26, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 26, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Colorcon
Harvard Business School
Cantor Fitzgerald
McKesson
Dow
Express Scripts
Cerilliant
Baxter
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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