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Last Updated: April 11, 2021

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Details for New Drug Application (NDA): 090742

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NDA 090742 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma Ltd, Casi Pharms Inc, Chartwell, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Qilu, Strides Pharma, and Teva Pharms Usa, and is included in ten NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 090742
Tradename:TENOFOVIR DISOPROXIL FUMARATE
Applicant:Strides Pharma
Ingredient:tenofovir disoproxil fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090742
Suppliers and Packaging for NDA: 090742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090742 ANDA AvPAK 50268-758 50268-758-12 20 BLISTER PACK in 1 BOX (50268-758-12) > 1 TABLET in 1 BLISTER PACK (50268-758-11)
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090742 ANDA DOH CENTRAL PHARMACY 53808-1128 53808-1128-1 30 TABLET in 1 BLISTER PACK (53808-1128-1)

Profile for product number 001

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

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