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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022488


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NDA 022488 describes LYRICA, which is a drug marketed by Upjohn and is included in three NDAs. It is available from five suppliers. There are three 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-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 022488
Tradename:LYRICA
Applicant:Upjohn
Ingredient:pregabalin
Patents:0
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)
LYRICA pregabalin SOLUTION;ORAL 022488 NDA AUTHORIZED GENERIC Greenstone LLC 59762-1576 59762-1576-1 1 BOTTLE in 1 CARTON (59762-1576-1) / 473 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Jan 4, 2010TE:AARLD:Yes

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