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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080776
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTISONE ACETATE CORTISONE ACETATE 25MG TABLET;ORAL Discontinued None 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
06/13/1972 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
05/07/2024 SUPPL-44 Labeling-Container/Carton Labels

Label is not available on this site.

03/22/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

11/16/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-30 Labeling

Label is not available on this site.

02/15/1995 SUPPL-29 Labeling

Label is not available on this site.

05/05/1994 SUPPL-28 Labeling

Label is not available on this site.

08/24/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/22/1988 SUPPL-22 Labeling

Label is not available on this site.

08/22/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/22/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/22/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/19/1988 SUPPL-13 Labeling

Label is not available on this site.

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