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Details for New Drug Application (NDA): 021446
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The generic ingredient in LYRICA is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 021446
Tradename: | LYRICA |
Applicant: | Pfizer |
Ingredient: | pregabalin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 021446
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 |
Paragraph IV (Patent) Challenges for 021446
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
LYRICA | CAPSULE;ORAL | pregabalin | 021446 | 2008-12-30 |
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: | May 3, 2021 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Regulatory Exclusivity Expiration: | Jun 22, 2020 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
Expired US Patents for NDA 021446
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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