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Last Updated: August 8, 2020

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Details for New Drug Application (NDA): 020978

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NDA 020978 describes ZIAGEN, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the ZIAGEN profile page.

The generic ingredient in ZIAGEN is abacavir sulfate. 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 profile page.
Summary for 020978
Tradename:ZIAGEN
Applicant:Viiv Hlthcare
Ingredient:abacavir sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020978
Suppliers and Packaging for NDA: 020978
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIAGEN abacavir sulfate SOLUTION;ORAL 020978 NDA ViiV Healthcare Company 49702-222 49702-222-48 1 BOTTLE in 1 CARTON (49702-222-48) > 240 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 020978
Tradename Dosage Ingredient NDA Submissiondate
ZIAGEN SOLUTION;ORAL abacavir sulfate 020978 2012-12-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Dec 17, 1998TE:AARLD:Yes

Expired US Patents for NDA 020978

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Harvard Business School
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Johnson and Johnson

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