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Generated: April 20, 2019

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Details for New Drug Application (NDA): 021652

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NDA 021652 describes EPZICOM, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from five suppliers. Additional details are available on the EPZICOM profile page.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 021652
Tradename:EPZICOM
Applicant:Viiv Hlthcare
Ingredient:abacavir sulfate; lamivudine
Patents:0
Pharmacology for NDA: 021652
Suppliers and Packaging for NDA: 021652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652 NDA REMEDYREPACK INC. 49349-701 49349-701-02 30 TABLET, FILM COATED in 1 BLISTER PACK (49349-701-02)
EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652 NDA REMEDYREPACK INC. 49349-701 49349-701-19 90 TABLET, FILM COATED in 1 CANISTER (49349-701-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021652

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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