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Generated: November 13, 2018

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Details for New Drug Application (NDA): 021992

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NDA 021992 describes PRISTIQ, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRISTIQ profile page.

The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 021992
Tradename:PRISTIQ
Applicant:Wyeth Pharms Inc
Ingredient:desvenlafaxine succinate
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021992
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1210 0008-1210-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1210-30)
PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1211 0008-1211-01 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 29, 2008TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 6, 2021
Regulatory Exclusivity Use:ADDITION OF DATA BASED ON THE ASSESSMENT OF SAFETY AND EFFICACY IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER TO FULFILL POSTMARKETING STUDY REQUIREMENT 1229-1
Patent:➤ Try a Free TrialPatent Expiration:Mar 1, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
Patent:➤ Try a Free TrialPatent Expiration:Mar 1, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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