Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008697
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTEF HYDROCORTISONE 10MG TABLET;ORAL Prescription AB Yes No
CORTEF HYDROCORTISONE 20MG TABLET;ORAL Prescription AB Yes Yes
CORTEF HYDROCORTISONE 5MG TABLET;ORAL Prescription AB Yes 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
12/15/1952 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/08/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf
09/08/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf
03/16/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/28/1993 SUPPL-21 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf
12/08/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/09/1983 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1978 SUPPL-14 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/08/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf
09/08/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf
12/28/1993 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf

CORTEF

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 10MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 040761 VINTAGE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 20MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 040761 VINTAGE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 5MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 040761 VINTAGE

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