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

Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Dec 17, 1998	TE:	AA	RLD:	Yes

Expired US Patents for NDA 020978

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

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