Application 017871
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEMSER | METYROSINE | CAPSULE;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25010-305 | Demser | metyrosine | Bausch Health Americas Inc. | NDA | Current |
| 25010-305 | Demser | metyrosine | Bausch Health US, LLC | NDA | Current |
| 25010-305 | Demser | metyrosine | Bausch Health US, LLC | NDA | Current |
| 25010-305 | Demser | metyrosine | Aton Pharma, Inc. | NDA | Current |
| 25010-305 | Demser | metyrosine | Bausch Health Americas Inc. | NDA | Current |
| 68682-310 | Metyrosine | Metyrosine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-310 | Metyrosine | Metyrosine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13940 | SUPPL | 2003-06-08 |