Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040612
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/12/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40612ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040612_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
08/06/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040612 | FRESENIUS KABI USA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202691 | HIKMA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |