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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. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the BARACLUDE profile page.

The generic ingredient in BARACLUDE 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: 021798

Bristol Myers Squibb
Therapeutic Class:Antivirals

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
Patent:5,206,244*PEDPatent Expiration:Aug 21, 2015Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 20, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Oct 12, 2015
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 021798

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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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