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Details for New Drug Application (NDA): 021205

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NDA 021205 describes TRIZIVIR, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRIZIVIR profile page.

The generic ingredient in TRIZIVIR is abacavir sulfate; lamivudine; zidovudine. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for NDA: 021205

Tradename:
TRIZIVIR
Applicant:
Viiv Hlthcare
Ingredient:
abacavir sulfate; lamivudine; zidovudine
Patents:3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021205

Suppliers and Packaging for NDA: 021205

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL 021205 NDA ViiV Healthcare Company 49702-217 49702-217-18 60 TABLET, FILM COATED in 1 BOTTLE (49702-217-18)
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL 021205 NDA State of Florida DOH Central Pharmacy 53808-0990 53808-0990-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0990-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE;150MG;300MG
Approval Date:Nov 14, 2000TE:ABRLD:Yes
Patent:5,905,082*PEDPatent Expiration:Nov 18, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,294,540*PEDPatent Expiration:Nov 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,417,191*PEDPatent Expiration:Sep 28, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021205

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20007,119,202*PED► subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20004,724,232► subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20004,837,208► subscribe
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