Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207549
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG 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 |
---|---|---|---|---|---|---|---|
11/09/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207549Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207549Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2024 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/07/2024 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/07/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/09/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207549Orig1s000lbl.pdf |
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION; EQ 40MG 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 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207549 | AMNEAL |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040583 | FRESENIUS KABI USA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203125 | HIKMA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |
INJECTABLE;INJECTION; EQ 125MG 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 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207549 | AMNEAL |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040583 | FRESENIUS KABI USA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203125 | HIKMA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |