Product NDC: | 45945-155 |
Proprietary Name: | Gablofen |
Non Proprietary Name: | baclofen |
Active Ingredient(s): | 500 ug/mL & nbsp; baclofen |
Administration Route(s): | INTRATHECAL |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 45945-155 |
Labeler Name: | Mallinckrodt Inc (Brand Pharmaceuticals) |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022462 |
Marketing Category: | NDA |
Start Marketing Date: | 20101119 |
Package NDC: | 45945-155-02 |
Package Description: | 20 mL in 1 VIAL, GLASS (45945-155-02) |
NDC Code | 45945-155-02 |
Proprietary Name | Gablofen |
Package Description | 20 mL in 1 VIAL, GLASS (45945-155-02) |
Product NDC | 45945-155 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | baclofen |
Dosage Form Name | INJECTION |
Route Name | INTRATHECAL |
Start Marketing Date | 20101119 |
Marketing Category Name | NDA |
Labeler Name | Mallinckrodt Inc (Brand Pharmaceuticals) |
Substance Name | BACLOFEN |
Strength Number | 500 |
Strength Unit | ug/mL |
Pharmaceutical Classes | GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] |