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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 203442


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NDA 203442 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Pharmacology for NDA: 203442
Suppliers and Packaging for NDA: 203442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203442 ANDA NorthStar RxLLC 16714-534 16714-534-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203442 ANDA Macleods Pharmaceuticals Limited 33342-106 33342-106-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-106-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:May 15, 2020TE:ABRLD:No

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