Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Colorcon
McKinsey
McKesson
Julphar
US Department of Justice

Generated: April 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021797

« Back to Dashboard

NDA 021797 describes BARACLUDE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the BARACLUDE profile page.

The generic ingredient in BARACLUDE is entecavir. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 021797
Tradename:BARACLUDE
Applicant:Bristol Myers Squibb
Ingredient:entecavir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021797
Suppliers and Packaging for NDA: 021797
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1611 0003-1611-12 1 BOTTLE in 1 CARTON (0003-1611-12) > 30 TABLET, FILM COATED in 1 BOTTLE
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1611 0003-1611-13 1 BOTTLE in 1 CARTON (0003-1611-13) > 90 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 29, 2005TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 29, 2005TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Baxter
AstraZeneca
Argus Health
Farmers Insurance
McKesson

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.