Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084283
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription AB No 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
09/09/1977 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
11/24/2008 SUPPL-41 Labeling

Label is not available on this site.

03/14/2003 SUPPL-33 Labeling

Label is not available on this site.

08/28/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-26 Labeling

Label is not available on this site.

06/09/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-24 Labeling

Label is not available on this site.

10/07/1994 SUPPL-23 Labeling

Label is not available on this site.

03/30/1994 SUPPL-22 Labeling

Label is not available on this site.

06/05/1991 SUPPL-21 Labeling

Label is not available on this site.

01/16/1990 SUPPL-18 Labeling

Label is not available on this site.

10/13/1989 SUPPL-17 Labeling

Label is not available on this site.

09/19/1989 SUPPL-16 Labeling

Label is not available on this site.

02/23/1988 SUPPL-14 Labeling

Label is not available on this site.

01/07/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 084283 HIKMA
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 088465 HIKMA PHARMS
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA

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