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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201806


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NDA 201806 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Hetero Labs Ltd Iii and is included in one NDA. It is available from one supplier. 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: 201806
Suppliers and Packaging for NDA: 201806
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 201806 ANDA Camber Pharmaceuticals, Inc. 31722-560 31722-560-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-560-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Oct 7, 2021TE:ABRLD:No

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