Details for New Drug Application (NDA): 203459
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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 203459
Tradename: | PREGABALIN |
Applicant: | Alembic |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 203459
Suppliers and Packaging for NDA: 203459
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 203459 | ANDA | Alembic Pharmaceuticals Limited | 46708-119 | 46708-119-10 | 100 CAPSULE in 1 CARTON (46708-119-10) |
PREGABALIN | pregabalin | CAPSULE;ORAL | 203459 | ANDA | Alembic Pharmaceuticals Limited | 46708-119 | 46708-119-30 | 30 CAPSULE in 1 BOTTLE (46708-119-30) |
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 |
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