Application 040794
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 40MG/ML | No | No |
| 002 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 80MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3131 | Methylprednisolone Acetate | Methylprednisolone Acetate | Sandoz Inc | ANDA | Current |
| 0781-3132 | Methylprednisolone Acetate | Methylprednisolone Acetate | Sandoz Inc | ANDA | Current |
| 21695-849 | Methylprednisolone Acetate | Methylprednisolone Acetate | Rebel Distributors Corp | ANDA | Current |
| 21695-850 | Methylprednisolone Acetate | Methylprednisolone Acetate | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22153 | ORIG | 2013-05-10 |