Details for New Drug Application (NDA): 209592
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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 209592
Tradename: | BACLOFEN |
Applicant: | Mylan Labs Ltd |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 209592
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 209592
Suppliers and Packaging for NDA: 209592
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | INJECTABLE;INTRATHECAL | 209592 | ANDA | Mylan Institutional LLC | 67457-562 | 67457-562-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-562-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
BACLOFEN | baclofen | INJECTABLE;INTRATHECAL | 209592 | ANDA | Mylan Institutional LLC | 67457-564 | 67457-564-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-564-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 0.5MG/ML | ||||
Approval Date: | Mar 21, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 2MG/ML | ||||
Approval Date: | Mar 21, 2018 | TE: | AP | RLD: | No |
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