Details for New Drug Application (NDA): 021446

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NDA 021446 describes LYRICA, which is a drug marketed by Upjohn and is included in three NDAs. It is available from nine 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 021446

Tradename:	LYRICA
Applicant:	Upjohn
Ingredient:	pregabalin
Patents:	0
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 BLISTER PACK in 1 CARTON (0071-1013-41) > 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 30, 2004	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 23, 2022
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Nov 23, 2022
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 30, 2004	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 23, 2022
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 021446

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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