Details for New Drug Application (NDA): 074584
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The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 074584
Tradename: | BACLOFEN |
Applicant: | Upsher Smith Labs |
Ingredient: | baclofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074584
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 074584
Suppliers and Packaging for NDA: 074584
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 074584 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1054 | 0832-1054-10 | 1000 TABLET in 1 BOTTLE (0832-1054-10) |
BACLOFEN | baclofen | TABLET;ORAL | 074584 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1054 | 0832-1054-11 | 100 TABLET in 1 BOTTLE (0832-1054-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 19, 1996 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Aug 19, 1996 | TE: | AB | RLD: | No |
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