Details for New Drug Application (NDA): 213226
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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 213226
Tradename: | PREGABALIN |
Applicant: | Msn |
Ingredient: | pregabalin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 213226
Suppliers and Packaging for NDA: 213226
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 213226 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-127 | 69539-127-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69539-127-30) |
PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 213226 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-128 | 69539-128-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69539-128-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 82.5MG | ||||
Approval Date: | Apr 13, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 165MG | ||||
Approval Date: | Apr 13, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 330MG | ||||
Approval Date: | Apr 13, 2021 | TE: | AB | RLD: | No |
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