Details for New Drug Application (NDA): 206452
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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 206452
Tradename: | PREGABALIN |
Applicant: | Cadila Pharms Ltd |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 206452
Suppliers and Packaging for NDA: 206452
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 206452 | ANDA | Cadila Pharmaceuticals Limited | 71209-032 | 71209-032-04 | 90 CAPSULE in 1 BOTTLE (71209-032-04) |
PREGABALIN | pregabalin | CAPSULE;ORAL | 206452 | ANDA | Cadila Pharmaceuticals Limited | 71209-033 | 71209-033-04 | 90 CAPSULE in 1 BOTTLE (71209-033-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 12, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 12, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Jul 12, 2023 | TE: | RLD: | No |
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