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Details for New Drug Application (NDA): 020977

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NDA 020977 describes ZIAGEN, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZIAGEN profile page.

The generic ingredient in ZIAGEN is abacavir sulfate. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the abacavir sulfate profile page.

Summary for NDA: 020977

Tradename:
ZIAGEN
Applicant:
Viiv Hlthcare
Ingredient:
abacavir sulfate
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020977

Suppliers and Packaging for NDA: 020977

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIAGEN
abacavir sulfate
TABLET;ORAL 020977 NDA ViiV Healthcare Company 49702-221 49702-221-18 1 BOTTLE in 1 CARTON (49702-221-18) > 60 TABLET, FILM COATED in 1 BOTTLE
ZIAGEN
abacavir sulfate
TABLET;ORAL 020977 NDA ViiV Healthcare Company 49702-221 49702-221-44 6 BLISTER PACK in 1 DOSE PACK (49702-221-44) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 17, 1998TE:ABRLD:Yes
Patent:6,294,540*PEDPatent Expiration:Nov 14, 2018Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Mar 23, 2018
Regulatory Exclusivity Use:ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION

Expired Orange Book Patents for NDA: 020977

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 19985,034,394*PED► subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 19985,089,500*PED► subscribe
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