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Details for New Drug Application (NDA): 021356

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NDA 021356 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: 021356

Gilead Sciences Inc
tenofovir disoproxil fumarate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021356

Suppliers and Packaging for NDA: 021356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tenofovir disoproxil fumarate
TABLET;ORAL 021356 NDA REMEDYREPACK INC. 24236-284 24236-284-02 30 TABLET, COATED in 1 BLISTER PACK (24236-284-02)
tenofovir disoproxil fumarate
TABLET;ORAL 021356 NDA A-S Medication Solutions 50090-0754 50090-0754-0 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-0754-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 26, 2001TE:ABRLD: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

Expired Orange Book Patents for NDA: 021356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 20014,808,716► subscribe
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