Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080292
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 5MG 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
05/22/1972 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
12/09/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/29/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/26/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/26/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-35 Labeling

Label is not available on this site.

04/02/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/14/1994 SUPPL-30 Labeling

Label is not available on this site.

06/15/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/09/1994 SUPPL-28 Labeling

Label is not available on this site.

06/15/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/14/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/05/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-19 Labeling

Label is not available on this site.

12/06/1988 SUPPL-18 Labeling

Label is not available on this site.

10/07/1988 SUPPL-17 Labeling

Label is not available on this site.

10/14/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/14/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/13/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080352 HIKMA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080292 MYLAN
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080356 WATSON LABS

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