Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011757
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription AB Yes Yes
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 20MG/ML INJECTABLE;INJECTION Prescription AB Yes Yes
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription AB 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
05/27/1959 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-114 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011757Orig1s114Ltr.pdf
03/15/2017 SUPPL-111 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011757Orig1s111ltr.pdf
09/08/2016 SUPPL-104 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011757Orig1s104ltr.pdf
07/03/2014 SUPPL-103 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011757Orig1s103ltr.pdf
06/09/2014 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

10/11/2013 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

10/07/2013 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

04/07/2009 SUPPL-86 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf
04/07/2009 SUPPL-85 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf
05/22/2002 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

01/24/1995 SUPPL-75 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/1994 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

12/28/1993 SUPPL-70 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1990 SUPPL-64 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/14/1989 SUPPL-63 Labeling

Label is not available on this site.

05/12/1986 SUPPL-60 Labeling

Label is not available on this site.

01/05/1989 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1983 SUPPL-58 Labeling

Label is not available on this site.

03/09/1983 SUPPL-57 Labeling

Label is not available on this site.

05/12/1986 SUPPL-55 Labeling

Label is not available on this site.

07/29/1980 SUPPL-54 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/12/1986 SUPPL-53 Labeling

Label is not available on this site.

07/12/1978 SUPPL-52 Labeling

Label is not available on this site.

02/17/1981 SUPPL-50 Manufacturing (CMC)-Control

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-114 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf
09/08/2016 SUPPL-104 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf
07/03/2014 SUPPL-103 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf
04/07/2009 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf
04/07/2009 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf

DEPO-MEDROL

INJECTABLE;INJECTION; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription Yes AB 011757 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 201835 SAGENT PHARMS INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040719 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040794 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040557 TEVA PHARMS USA
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040620 TEVA PHARMS USA

INJECTABLE;INJECTION; 20MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 20MG/ML INJECTABLE;INJECTION Prescription Yes AB 011757 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 20MG/ML INJECTABLE;INJECTION Prescription No AB 201835 SAGENT PHARMS INC

INJECTABLE;INJECTION; 80MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription Yes AB 011757 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 201835 SAGENT PHARMS INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040719 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040794 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040557 TEVA PHARMS USA
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040620 TEVA PHARMS USA

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