Details for New Drug Application (NDA): 072234
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The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 072234
Tradename: | BACLOFEN |
Applicant: | Ivax Sub Teva Pharms |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 072234
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 072234
Suppliers and Packaging for NDA: 072234
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 072234 | ANDA | Teva Pharmaceuticals USA, Inc. | 0172-4096 | 0172-4096-60 | 100 TABLET in 1 BOTTLE (0172-4096-60) |
BACLOFEN | baclofen | TABLET;ORAL | 072234 | ANDA | Teva Pharmaceuticals USA, Inc. | 0172-4096 | 0172-4096-80 | 1000 TABLET in 1 BOTTLE (0172-4096-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 21, 1988 | TE: | AB | RLD: | No |
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