Details for New Drug Application (NDA): 214496
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The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 214496
Tradename: | PREGABALIN |
Applicant: | Epic Pharma Llc |
Ingredient: | pregabalin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 214496
Suppliers and Packaging for NDA: 214496
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 214496 | ANDA | Sinotherapeutics Inc. | 69986-013 | 69986-013-01 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69986-013-01) |
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 214496 | ANDA | Sinotherapeutics Inc. | 69986-014 | 69986-014-01 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69986-014-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 82.5MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 165MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 330MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
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