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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 five suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are thirty-three drug master file entries for this compound. Five suppliers are listed for this compound. There are fourteen tentative approvals for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for NDA: 022577

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022577

Suppliers and Packaging for NDA: 022577

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength40MG/SCOOPFUL
Approval Date:Jan 18, 2012TE:RLD:Yes
Patent:5,922,695*PEDPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:5,935,946*PEDPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:5,977,089*PEDPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.