Details for New Drug Application (NDA): 210315
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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 210315
Tradename: | BACLOFEN |
Applicant: | Maia Pharms Inc |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 210315
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 210315
Suppliers and Packaging for NDA: 210315
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | INJECTABLE;INTRATHECAL | 210315 | ANDA | Sagent Pharmaceuticals | 25021-680 | 25021-680-20 | 1 VIAL in 1 CARTON (25021-680-20) / 20 mL in 1 VIAL |
BACLOFEN | baclofen | INJECTABLE;INTRATHECAL | 210315 | ANDA | MAlA Pharmaceuticals, Inc. | 70511-123 | 70511-123-20 | 1 VIAL, GLASS in 1 CARTON (70511-123-20) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 1MG/ML | ||||
Approval Date: | Jul 30, 2019 | TE: | AP | RLD: | No |
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