Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009866
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription None 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
04/27/1955 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
05/27/2021 SUPPL-115 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009866s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf
11/21/2019 SUPPL-113 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009866s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/009866Orig1s113ltr.pdf
02/25/2016 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

09/08/2016 SUPPL-105 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf
07/03/2014 SUPPL-104 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009866Orig1s104ltr.pdf
06/24/2014 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

06/09/2014 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

07/22/2014 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

03/28/2014 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

09/08/2016 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf
09/27/2013 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

04/04/2014 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

09/06/2014 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

09/23/2015 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

06/16/2010 SUPPL-80 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009866s080ltr.pdf
09/01/2009 SUPPL-79 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s079ltr.pdf
09/01/2009 SUPPL-77 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s79ltr.pdf
10/21/2002 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

11/25/1999 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1994 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1994 SUPPL-65 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/1994 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1993 SUPPL-61 Labeling

Label is not available on this site.

04/01/1991 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1990 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1990 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1988 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

07/02/1987 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1987 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/1985 SUPPL-51 Labeling

Label is not available on this site.

03/22/1989 SUPPL-50 Labeling

Label is not available on this site.

12/15/1981 SUPPL-47 Labeling

Label is not available on this site.

12/15/1981 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/14/1980 SUPPL-45 Labeling

Label is not available on this site.

09/24/1979 SUPPL-44 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/18/1979 SUPPL-43 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/27/2021 SUPPL-115 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009866s115lbl.pdf
11/21/2019 SUPPL-113 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009866s113lbl.pdf
09/08/2016 SUPPL-105 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf
09/08/2016 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf
07/03/2014 SUPPL-104 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf
06/16/2010 SUPPL-80 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf
09/01/2009 SUPPL-79 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf
09/01/2009 SUPPL-77 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf

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