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Details for New Drug Application (NDA): 022108

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NDA 022108 describes APLENZIN, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the APLENZIN profile page.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the bupropion hydrobromide profile page.

Summary for NDA: 022108

Tradename:
APLENZIN
Applicant:
Valeant Pharms North
Ingredient:
bupropion hydrobromide
Patents:8
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL 022108 NDA sanofi-aventis U.S. LLC 0024-5810 0024-5810-07 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5810-07)
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL 022108 NDA sanofi-aventis U.S. LLC 0024-5810 0024-5810-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0024-5810-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength174MG
Approval Date:Apr 23, 2008TE:RLD:No
Patent:7,241,805Patent Expiration:Jun 27, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,572,935Patent Expiration:Jun 27, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,585,897Patent Expiration:Jun 27, 2026Product Flag?YSubstance 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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