Details for New Drug Application (NDA): 021515

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NDA 021515 describes WELLBUTRIN XL, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the WELLBUTRIN XL profile page.

The generic ingredient in WELLBUTRIN XL 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 021515

Tradename:	WELLBUTRIN XL
Applicant:	Bausch
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 021515

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

Suppliers and Packaging for NDA: 021515

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515	NDA	Bausch Health US LLC	0187-0730	0187-0730-07	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0730-07)
WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515	NDA	Bausch Health US LLC	0187-0730	0187-0730-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0730-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Aug 28, 2003	TE:	AB3	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Aug 28, 2003	TE:	AB3	RLD:	Yes

Expired US Patents for NDA 021515

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-002	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-002	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
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