Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083365
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription AB No No
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription AB No No
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription AB No 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
06/18/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2017 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

06/28/2017 SUPPL-45 Labeling-Container/Carton Labels

Label is not available on this site.

06/28/2017 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

02/13/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

06/28/2017 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

02/23/2015 SUPPL-40 Labeling

Label is not available on this site.

07/15/2002 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2000 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/08/1995 SUPPL-30 Labeling

Label is not available on this site.

05/23/1994 SUPPL-29 Labeling

Label is not available on this site.

04/22/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/05/1991 SUPPL-24 Labeling

Label is not available on this site.

04/03/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/03/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/09/1990 SUPPL-19 Labeling

Label is not available on this site.

10/14/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/05/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/13/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/13/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

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

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

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