Details for New Drug Application (NDA): 020358

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NDA 020358 describes WELLBUTRIN SR, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the WELLBUTRIN SR profile page.

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

Summary for 020358

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

Pharmacology for NDA: 020358

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Suppliers and Packaging for NDA: 020358

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358	NDA	GlaxoSmithKline LLC	0173-0135	0173-0135-55	60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55)
WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358	NDA	GlaxoSmithKline LLC	0173-0722	0173-0722-00	60 TABLET, FILM COATED in 1 BOTTLE (0173-0722-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Oct 4, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Oct 4, 1996	TE:	AB1	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Oct 4, 1996	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 020358

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	⤷ Sign Up	⤷ Sign Up
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