Application 208193
- Type
- NDA
- Sponsor
- METACEL PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OZOBAX | BACLOFEN | SOLUTION;ORAL | 5MG/5ML | Yes | Yes |
| 002 | OZOBAX DS | BACLOFEN | SOLUTION;ORAL | 10MG/5ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68134-401 | BACLOFEN | Baclofen | Palmetto Pharmaceuticals Inc. | NDA | Current |
| 68134-401 | BACLOFEN | Baclofen | Palmetto Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 69528-301 | OZOBAX | Baclofen | Metacel Pharmaceuticals, LLC | NDA | Current |
| 69528-301 | OZOBAX | Baclofen | Metacel Pharmaceuticals, LLC | NDA | Current |
| 69528-301 | OZOBAX | Baclofen | Metacel Pharmaceuticals, LLC | NDA | Current |
| 69528-301 | OZOBAX | Baclofen | Metacel Pharmaceuticals, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81235 | SUPPL | 2025-02-12 |
| 62552 | ORIG | 2020-04-13 |
| 60044 | ORIG | 2019-09-19 |
| 60042 | ORIG | 2019-09-19 |