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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021515

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NDA 021515 describes WELLBUTRIN XL, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Eighty-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 021515
Tradename:WELLBUTRIN XL
Applicant:Valeant Intl
Ingredient:bupropion hydrochloride
Patents:1
Formulation / Manufacturing:see details
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 Valeant Pharmaceuticals North America 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 Valeant Pharmaceuticals North America 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
Patent:➤ Sign UpPatent Expiration:Oct 30, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 30, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021515

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