Application 201835
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 20MG/ML | No | No |
| 002 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 40MG/ML | No | No |
| 003 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 80MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-820 | methylprednisolone acetate | methylprednisolone acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-820 | methylprednisolone acetate | methylprednisolone acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-821 | methylprednisolone acetate | methylprednisolone acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-821 | methylprednisolone acetate | methylprednisolone acetate | Sagent Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64842 | ORIG | 2020-10-06 |