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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090636


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NDA 090636 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 090636
Pharmacology for NDA: 090636
Suppliers and Packaging for NDA: 090636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636 ANDA NorthStar RxLLC 16714-820 16714-820-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-820-01)
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636 ANDA Camber Pharmaceuticals, Inc. 31722-535 31722-535-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 26, 2018TE:ABRLD:No

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