Details for New Drug Application (NDA): 209501
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NDA 209501 describes LYRICA CR, which is a drug marketed by Upjohn and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and four Paragraph IV challenges. Additional details are available on the LYRICA CR profile page.
The generic ingredient in LYRICA CR 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.
The generic ingredient in LYRICA CR 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 209501
| Tradename: | LYRICA CR |
| Applicant: | Upjohn |
| Ingredient: | pregabalin |
| Patents: | 3 |
Medical Subject Heading (MeSH) Categories for 209501
Suppliers and Packaging for NDA: 209501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501 | NDA | Viatris Specialty LLC | 58151-245 | 58151-245-93 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93) |
| LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501 | NDA | Viatris Specialty LLC | 58151-246 | 58151-246-93 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-246-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 82.5MG | ||||
| Approval Date: | Oct 11, 2017 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,022,447*PED | Patent Expiration: | May 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,945,620*PED | Patent Expiration: | May 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,144,559*PED | Patent Expiration: | May 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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