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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 022577

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NDA 022577 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for 022577

Tradename:	VIREAD
Applicant:	Gilead Sciences Inc
Ingredient:	tenofovir disoproxil fumarate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022577

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 022577

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577	NDA	Gilead Sciences, Inc.	61958-0403	61958-0403-1	1 BOTTLE, PLASTIC in 1 CARTON (61958-0403-1) / 60 g in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	40MG/SCOOPFUL
Approval Date:	Jan 18, 2012	TE:		RLD:	Yes

Expired US Patents for NDA 022577

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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