Application 020189
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FELBATOL | FELBAMATE | TABLET;ORAL | 400MG | Yes | No |
| 002 | FELBATOL | FELBAMATE | TABLET;ORAL | 600MG | Yes | Yes |
| 003 | FELBATOL | FELBAMATE | SUSPENSION;ORAL | 600MG/5ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-0430 | Felbatol | felbamate | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-0430 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0430 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0430 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0430 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0431 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0431 | Felbatol | felbamate | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-0431 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0431 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0431 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0442 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0442 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0442 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 0037-0442 | Felbatol | felbamate | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-0442 | Felbatol | felbamate | Meda Pharmaceuticals | NDA | Current |
| 51525-0430 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0430 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0430 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0430 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0431 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0431 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0431 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0431 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0442 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0442 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0442 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0442 | Felbamate | felbamate | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43641 | SUPPL | 2012-09-06 |
| 12311 | SUPPL | 2012-09-06 |
| 24556 | SUPPL | 2012-09-05 |
| 34356 | SUPPL | 2011-07-07 |
| 24555 | SUPPL | 2011-07-07 |
| 12310 | SUPPL | 2009-05-13 |
| 24554 | SUPPL | 2009-05-01 |
| 24142 | ORIG | 2008-02-01 |
| 2153 | SUPPL | 2002-11-19 |