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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 020857


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NDA 020857 describes COMBIVIR, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the COMBIVIR profile page.

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for 020857
Tradename:COMBIVIR
Applicant:Viiv Hlthcare
Ingredient:lamivudine; zidovudine
Patents:0
Pharmacology for NDA: 020857
Suppliers and Packaging for NDA: 020857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857 NDA ViiV Healthcare Company 49702-202 49702-202-18 60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG;300MG
Approval Date:Sep 26, 1997TE:RLD:Yes

Expired US Patents for NDA 020857

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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