Details for New Drug Application (NDA): 208193
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NDA 208193 describes OZOBAX DS, which is a drug marketed by Metacel Pharms Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the OZOBAX DS profile page.
The generic ingredient in OZOBAX DS is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.
The generic ingredient in OZOBAX DS is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three 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: | 10,610,502 | 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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