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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 six 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 fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

Summary for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 29, 2008TE:ABRLD:Yes
Patent:8,269,040Patent Expiration:Jul 5, 2027Product Flag?Substance Flag?YDelist Request?
Patent:6,673,838Patent Expiration:Mar 1, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
Regulatory Exclusivity Expiration:Feb 14, 2016
Regulatory Exclusivity Use:MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER


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