Application 011011
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 004 | ROBAXIN | METHOCARBAMOL | TABLET;ORAL | 500MG | Yes | No |
| 006 | ROBAXIN-750 | METHOCARBAMOL | TABLET;ORAL | 750MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52244-429 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 63487 | SUPPL | 2020-06-12 |
| 57893 | SUPPL | 2019-03-05 |
| 11919 | SUPPL | 2003-05-16 |
| 248 | SUPPL | 2003-05-16 |
| 33034 | SUPPL | 2003-05-06 |
| 10756 | SUPPL | 2003-05-06 |