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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 020711

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NDA 020711 describes ZYBAN, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the ZYBAN profile page.

The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 020711

Tradename:	ZYBAN
Applicant:	Glaxosmithkline
Ingredient:	bupropion hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	May 14, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 14, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020711

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-002	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-002	May 14, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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