Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011856
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/18/1959 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-141 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011856s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011856Orig1s141ltr.pdf | |
| 10/27/2021 | SUPPL-139 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s139lbl.pdf | |
| 05/27/2021 | SUPPL-136 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf | |
| 07/24/2018 | SUPPL-133 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s133Ltr.pdf | |
| 03/28/2018 | SUPPL-131 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s131ltr.pdf | |
| 08/06/2015 | SUPPL-127 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/2016 | SUPPL-126 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf | |
| 09/08/2016 | SUPPL-124 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf | |
| 07/03/2014 | SUPPL-123 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011856Orig1s123ltr.pdf | |
| 06/09/2014 | SUPPL-122 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2014 | SUPPL-121 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-119 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2014 | SUPPL-116 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/2010 | SUPPL-107 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/011856s107ltr.pdf | |
| 10/20/2011 | SUPPL-104 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf | |
| 10/20/2011 | SUPPL-103 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf | |
| 10/21/2002 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1998 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1994 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1994 | SUPPL-84 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/25/1994 | SUPPL-81 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1993 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1991 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1994 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1990 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-68 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/1989 | SUPPL-67 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/23/1986 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-60 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1985 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1989 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 05/03/1983 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/27/1985 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1981 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 10/16/1981 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1980 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1980 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1981 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/13/1979 | SUPPL-43 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-141 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011856s141lbl.pdf | |
| 10/27/2021 | SUPPL-139 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s139lbl.pdf |
| 05/27/2021 | SUPPL-136 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s136lbl.pdf | |
| 07/24/2018 | SUPPL-133 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s133lbl.pdf | |
| 03/28/2018 | SUPPL-131 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s131lbl.pdf | |
| 09/08/2016 | SUPPL-126 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf | |
| 09/08/2016 | SUPPL-124 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf | |
| 07/03/2014 | SUPPL-123 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf | |
| 10/20/2011 | SUPPL-104 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf | |
| 10/20/2011 | SUPPL-103 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf |
| 06/24/2010 | SUPPL-107 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf |
SOLU-MEDROL
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 |
INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202691 | HIKMA |
| METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
| METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |
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 |
INJECTABLE;INJECTION; EQ 2GM 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 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
| METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |