Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087342
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 20MG 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
05/15/1981 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-38 Labeling

Label is not available on this site.

02/13/2003 SUPPL-30 Labeling

Label is not available on this site.

08/28/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-23 Labeling

Label is not available on this site.

06/09/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-21 Labeling

Label is not available on this site.

10/07/1994 SUPPL-20 Labeling

Label is not available on this site.

03/30/1994 SUPPL-19 Labeling

Label is not available on this site.

06/05/1991 SUPPL-18 Labeling

Label is not available on this site.

12/26/1989 SUPPL-16 Labeling

Label is not available on this site.

10/13/1989 SUPPL-15 Labeling

Label is not available on this site.

11/14/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/28/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 087342 HIKMA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 083677 MYLAN
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 040392 VINTAGE PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 085161 WATSON LABS

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