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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 018644

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NDA 018644 describes WELLBUTRIN, which is a drug marketed by Glaxosmithkline and Bausch and is included in three NDAs. Additional details are available on the WELLBUTRIN profile page.

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

Summary for 018644

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018644

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	⤷ Get Started Free	⤷ Get Started Free
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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