Details for New Drug Application (NDA): 021039

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NDA 021039 describes AGENERASE, which is a drug marketed by Glaxosmithkline and is included in two NDAs. Additional details are available on the AGENERASE profile page.

The generic ingredient in AGENERASE is amprenavir. There are five drug master file entries for this compound. Additional details are available on the amprenavir profile page.

Summary for 021039

Tradename:	AGENERASE
Applicant:	Glaxosmithkline
Ingredient:	amprenavir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 15, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021039

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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