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Generated: April 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021798

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NDA 021798 describes BARACLUDE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. Additional details are available on the BARACLUDE profile page.

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

Summary for NDA: 021798

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021798

Suppliers and Packaging for NDA: 021798

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 021798 NDA E.R. Squibb & Sons, L.L.C. 0003-1614 0003-1614-12 1 BOTTLE in 1 CARTON (0003-1614-12) > 210 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.05MG/ML
Approval Date:Mar 29, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Sep 20, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 021798

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SOLUTION;ORAL021798-001Mar 29, 20055,206,244*PED► Subscribe
Bristol Myers Squibb
SOLUTION;ORAL021798-001Mar 29, 20055,908,638► Subscribe
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