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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008697
Company: PHARMACIA AND UPJOHN

Products on NDA 008697

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008697

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
06/05/2024	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008697s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008697Orig1s040ltr.pdf
12/20/2023	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008697s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008697Orig1s038ltr.pdf
11/21/2019	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008697s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008697Orig1s036ltr.pdf
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.

Labels for NDA 008697

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008697s040lbl.pdf
12/20/2023	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008697s038lbl.pdf
11/21/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008697s036lbl.pdf
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

Therapeutic Equivalents for NDA 008697

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	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	217160	HIBROW HLTHCARE
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

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	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	217160	HIBROW HLTHCARE
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

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	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	217160	HIBROW HLTHCARE
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

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