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 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 021446

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

Medical Subject Heading (MeSH) Categories for 021446

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 30, 2004	TE:		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:	➤ Sign Up	Patent Expiration:	Dec 30, 2018	Product Flag?		Substance Flag?		Delist Request?	Y
Patented Use:	MANAGEMENT OF FIBROMYALGIA

Expired US Patents for NDA 021446

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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