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Last Updated: January 21, 2020

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Details for New Drug Application (NDA): 018644

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NDA 018644 describes WELLBUTRIN, which is a drug marketed by Glaxosmithkline and Valeant Intl 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. Sixty-seven 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
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 018644
Tradename Dosage Ingredient NDA Submissiondate
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1985TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1985TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1985TE:RLD:Yes

Expired US Patents for NDA 018644

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

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