Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011856
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
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
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
A-METHAPRED METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040664 HOSPIRA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207549 AMNEAL PHARMS CO
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207667 AUROBINDO PHARMA LTD
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 040888 SAGENT PHARMS
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
A-METHAPRED METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040665 HOSPIRA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207549 AMNEAL PHARMS CO
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207667 AUROBINDO PHARMA LTD
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 040888 SAGENT PHARMS
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 207667 AUROBINDO PHARMA LTD
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
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
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 207667 AUROBINDO PHARMA LTD
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040888 SAGENT PHARMS
SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011856 PHARMACIA AND UPJOHN

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