Details for New Drug Application (NDA): 021797

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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. Sixteen 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

Pharmacology for NDA: 021797

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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.	0003-1612	0003-1612-12	1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 29, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Mar 29, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021797

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005	5,206,244*PED	⤷ Get Started Free
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005	5,206,244*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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