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Last Updated: November 21, 2024

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-seven 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
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes

Expired US Patents for NDA 021515

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021515-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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