Details for New Drug Application (NDA): 208193
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The generic ingredient in OZOBAX DS 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 208193
Tradename: | OZOBAX DS |
Applicant: | Metacel Pharms Llc |
Ingredient: | baclofen |
Patents: | 1 |
Pharmacology for NDA: 208193
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 208193
Suppliers and Packaging for NDA: 208193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OZOBAX | baclofen | SOLUTION;ORAL | 208193 | NDA AUTHORIZED GENERIC | TRUPHARMA, LLC | 52817-620 | 52817-620-08 | 237 mL in 1 BOTTLE (52817-620-08) |
OZOBAX | baclofen | SOLUTION;ORAL | 208193 | NDA AUTHORIZED GENERIC | Palmetto Pharmaceuticals Inc. | 68134-401 | 68134-401-16 | 473 mL in 1 BOTTLE (68134-401-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Sep 18, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 30, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SPASTICITY |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
Approval Date: | Oct 12, 2023 | TE: | RLD: | Yes |
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