Details for New Drug Application (NDA): 215675
✉ Email this page to a colleague
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 215675
Tradename: | PREGABALIN |
Applicant: | Sciegen Pharms Inc |
Ingredient: | pregabalin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 215675
Suppliers and Packaging for NDA: 215675
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 215675 | ANDA | ScieGen Pharmaceuticals, INC. | 50228-462 | 50228-462-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05) |
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 215675 | ANDA | ScieGen Pharmaceuticals, INC. | 50228-462 | 50228-462-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 82.5MG | ||||
Approval Date: | Sep 14, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 165MG | ||||
Approval Date: | Sep 14, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 330MG | ||||
Approval Date: | Sep 14, 2022 | TE: | RLD: | No |
Complete Access Available with Subscription