Details for New Drug Application (NDA): 211384
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The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 211384
Tradename: | PREGABALIN |
Applicant: | Invagen Pharms |
Ingredient: | pregabalin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211384
Suppliers and Packaging for NDA: 211384
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 211384 | ANDA | Cipla USA, Inc. | 69097-954 | 69097-954-05 | 90 CAPSULE in 1 BOTTLE (69097-954-05) |
PREGABALIN | pregabalin | CAPSULE;ORAL | 211384 | ANDA | Cipla USA, Inc. | 69097-954 | 69097-954-12 | 500 CAPSULE in 1 BOTTLE (69097-954-12) |
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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