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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 seven 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-six drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for NDA: 021515

Tradename:
WELLBUTRIN XL
Applicant:
Valeant Intl
Ingredient:
bupropion hydrochloride
Patents:1
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Aug 28, 2003TE:AB3RLD:No
Patent:6,096,341Patent Expiration:Oct 30, 2018Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes
Patent:6,096,341Patent Expiration:Oct 30, 2018Product Flag?Substance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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