Details for New Drug Application (NDA): 217252
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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 217252
Tradename: | BACLOFEN |
Applicant: | Ani Pharms |
Ingredient: | baclofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217252
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 217252
Suppliers and Packaging for NDA: 217252
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | SUSPENSION;ORAL | 217252 | ANDA | ANI Pharmaceuticals, Inc. | 62559-204 | 62559-204-03 | 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE |
BACLOFEN | baclofen | SUSPENSION;ORAL | 217252 | ANDA | ANI Pharmaceuticals, Inc. | 62559-204 | 62559-204-12 | 1 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | Jun 8, 2023 | TE: | AB | RLD: | No |
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