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Last Updated: December 3, 2022

Details for New Drug Application (NDA): 021992


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NDA 021992 describes PRISTIQ, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from three 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. Eighteen suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 021992
Tradename:PRISTIQ
Applicant:Pf Prism Cv
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 LLC, 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 LLC, 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
Patent:See Plans and PricingPatent Expiration:Mar 1, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
Patent:See Plans and PricingPatent Expiration:Mar 1, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:See Plans and PricingPatent Expiration:Jul 5, 2027Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 021992

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-002 Feb 29, 2008 See Plans and Pricing See Plans and Pricing
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-003 Aug 20, 2014 See Plans and Pricing See Plans and Pricing
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-002 Feb 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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