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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 215389


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NDA 215389 describes DARUNAVIR, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Teva Pharms Usa, and Zydus Lifesciences, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the DARUNAVIR profile page.

The generic ingredient in DARUNAVIR is darunavir. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
Summary for 215389
Tradename:DARUNAVIR
Applicant:Msn
Ingredient:darunavir
Patents:0
Suppliers and Packaging for NDA: 215389
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARUNAVIR darunavir TABLET;ORAL 215389 ANDA Novadoz Pharmaceuticals LLC 72205-184 72205-184-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-184-60)
DARUNAVIR darunavir TABLET;ORAL 215389 ANDA Novadoz Pharmaceuticals LLC 72205-185 72205-185-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-185-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Nov 28, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Nov 28, 2023TE:ABRLD:No

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