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 four 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-four 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

Medical Subject Heading (MeSH) Categories for 022488

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

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	Viatris Specialty LLC	58151-244	58151-244-35	473 mL in 1 BOTTLE (58151-244-35)
LYRICA	pregabalin	SOLUTION;ORAL	022488	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	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:	RX	Dosage:	SOLUTION;ORAL			Strength	20MG/ML
Approval Date:	Jan 4, 2010	TE:	AA	RLD:	Yes

Expired US Patents for NDA 022488

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010	5,563,175	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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