Details for New Drug Application (NDA): 077241
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The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 077241
Tradename: | BACLOFEN |
Applicant: | Lannett Co Inc |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 077241
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 077241
Suppliers and Packaging for NDA: 077241
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 077241 | ANDA | Lannett Company, Inc. | 0527-1333 | 0527-1333-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01) |
BACLOFEN | baclofen | TABLET;ORAL | 077241 | ANDA | Lannett Company, Inc. | 0527-1337 | 0527-1337-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1337-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 20, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 6, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 22, 2021 | TE: | AB | RLD: | No |
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