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Generated: April 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204003

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NDA 204003 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Alembic Pharms Ltd, Sandoz Inc, Actavis Labs Fl Inc, Lupin Ltd, West-ward Pharms Int, and Mylan Pharms Inc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the DESVENLAFAXINE SUCCINATE profile page.

The generic ingredient in DESVENLAFAXINE SUCCINATE is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

Summary for NDA: 204003

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL 204003 ANDA Alembic Pharmaceuticals Limited 46708-251 46708-251-08 80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-251-08)
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL 204003 ANDA Alembic Pharmaceuticals Limited 46708-251 46708-251-10 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-251-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE


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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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