Details for New Drug Application (NDA): 211685
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The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 211685
Tradename: | PREGABALIN |
Applicant: | Apotex |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211685
Suppliers and Packaging for NDA: 211685
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 211685 | ANDA | A-S Medication Solutions | 50090-6477 | 50090-6477-0 | 90 CAPSULE in 1 BOTTLE (50090-6477-0) |
PREGABALIN | pregabalin | CAPSULE;ORAL | 211685 | ANDA | ApotexCorp | 60505-3793 | 60505-3793-9 | 90 CAPSULE in 1 BOTTLE (60505-3793-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No |
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