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 six 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-six 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

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 30, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Dec 30, 2004	TE:	AB	RLD:	Yes

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	021446-001	Dec 30, 2004	⤷ Sign Up	⤷ Sign Up
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004	⤷ Sign Up	⤷ Sign Up
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	⤷ Sign Up	⤷ Sign Up
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	⤷ Sign Up	⤷ Sign Up
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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