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Details for New Drug Application (NDA): 021446

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NDA 021446 describes LYRICA, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from eleven suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LYRICA profile page.

The generic ingredient in LYRICA is pregabalin. There are thirty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. There are ninety-one tentative approvals for this compound. Additional details are available on the pregabalin profile page.

Summary for NDA: 021446

Tradename:
LYRICA
Applicant:
Pf Prism Cv
Ingredient:
pregabalin
Patents:3
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021446

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYRICA
pregabalin
CAPSULE;ORAL 021446 NDA Parke-Davis Div of Pfizer Inc 0071-1012 0071-1012-68 90 CAPSULE in 1 BOTTLE (0071-1012-68)
LYRICA
pregabalin
CAPSULE;ORAL 021446 NDA Parke-Davis Div of Pfizer Inc 0071-1013 0071-1013-41 100 CAPSULE in 1 BLISTER PACK (0071-1013-41)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 30, 2004TE:RLD:No
Patent:6,197,819Patent Expiration:Dec 30, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:6,001,876Patent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:MANAGEMENT OF FIBROMYALGIA
Patent:6,001,876Patent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATMENT OF PAIN

Expired Orange Book Patents for NDA: 021446

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 20045,563,175► subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 20045,563,175► subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 20045,563,175► subscribe
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