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Generated: November 15, 2018

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Details for New Drug Application (NDA): 022488

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NDA 022488 describes LYRICA, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from ten suppliers. There are six patents protecting this drug and six Paragraph IV challenges. Additional details are available on the LYRICA profile page.

The generic ingredient in LYRICA is pregabalin. There are forty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 022488
Tradename:LYRICA
Applicant:Pf Prism Cv
Ingredient:pregabalin
Patents:3
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022488
Suppliers and Packaging for NDA: 022488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYRICA pregabalin SOLUTION;ORAL 022488 NDA Parke-Davis Div of Pfizer Inc 0071-1020 0071-1020-01 473 mL in 1 BOTTLE (0071-1020-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Jan 4, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
Regulatory Exclusivity Expiration:May 3, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:MANAGEMENT OF FIBROMYALGIA

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