Details for New Drug Application (NDA): 209594
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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 209594
Tradename: | BACLOFEN |
Applicant: | Mylan Labs Ltd |
Ingredient: | baclofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209594
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 209594
Suppliers and Packaging for NDA: 209594
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | INJECTABLE;INTRATHECAL | 209594 | ANDA | Mylan Institutional LLC | 67457-563 | 67457-563-20 | 1 VIAL, GLASS in 1 CARTON (67457-563-20) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 1MG/ML | ||||
Approval Date: | Mar 6, 2018 | TE: | AP | RLD: | No |
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