Details for New Drug Application (NDA): 207623
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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 207623
Tradename: | PREGABALIN |
Applicant: | Alkem Labs Ltd |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 207623
Suppliers and Packaging for NDA: 207623
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | SOLUTION;ORAL | 207623 | ANDA | Ascend Laboratories, LLC | 67877-457 | 67877-457-47 | 473 mL in 1 BOTTLE (67877-457-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 20MG/ML | ||||
Approval Date: | Jul 19, 2019 | TE: | AA | RLD: | No |
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