Application 208400
- Type
- NDA
- Sponsor
- SILVERGATE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XATMEP | METHOTREXATE SODIUM | SOLUTION;ORAL | EQ 2MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52652-2001 | Xatmep | Methotrexate | Silvergate Pharmaceuticals, Inc. | NDA | Current |
| 52652-2001 | Xatmep | Methotrexate | Azurity Pharmaceuticals, Inc. | NDA | Current |
| 52652-2001 | Xatmep | Methotrexate | Azurity Pharmaceuticals, Inc. | NDA | Current |
| 52652-2001 | Xatmep | Methotrexate | Azurity Pharmaceuticals, Inc. | NDA | Current |
| 52652-2001 | Xatmep | Methotrexate | Silvergate Pharmaceuticals, Inc. | NDA | Current |