Details for New Drug Application (NDA): 210432
✉ 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-six suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 210432
Tradename: | PREGABALIN |
Applicant: | Rising |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210432
Suppliers and Packaging for NDA: 210432
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 210432 | ANDA | Major Pharmaceuticals | 0904-6991 | 0904-6991-04 | 30 BLISTER PACK in 1 CARTON (0904-6991-04) / 1 CAPSULE in 1 BLISTER PACK |
PREGABALIN | pregabalin | CAPSULE;ORAL | 210432 | ANDA | Major Pharmaceuticals | 0904-6991 | 0904-6991-61 | 100 BLISTER PACK in 1 CARTON (0904-6991-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription