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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090647


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NDA 090647 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan Labs Ltd, Norvium Bioscience, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fifteen suppliers. Additional details are available on the TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 090647
Pharmacology for NDA: 090647
Suppliers and Packaging for NDA: 090647
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647 ANDA Aurobindo Pharma Limited 65862-421 65862-421-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-421-30)
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647 ANDA Aurobindo Pharma Limited 65862-818 65862-818-03 3 BLISTER PACK in 1 CARTON (65862-818-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 26, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 26, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 26, 2018TE:ABRLD:No

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