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Generated: January 22, 2019

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Details for New Drug Application (NDA): 209501

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NDA 209501 describes LYRICA CR, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and four Paragraph IV challenges. Additional details are available on the LYRICA CR profile page.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one 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 209501
Tradename:LYRICA CR
Applicant:Pf Prism Cv
Ingredient:pregabalin
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209501
Suppliers and Packaging for NDA: 209501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501 NDA Parke-Davis Div of Pfizer Inc 0071-1026 0071-1026-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0071-1026-01)
LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501 NDA Parke-Davis Div of Pfizer Inc 0071-1027 0071-1027-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0071-1027-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength82.5MG
Approval Date:Oct 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 11, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Apr 11, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:May 2, 2027Product Flag?Substance Flag?Delist Request?Y

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