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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083677
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 20MG 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
02/26/1974 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
02/21/2019 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

04/10/2002 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/2000 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/29/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/18/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/14/1994 SUPPL-38 Labeling

Label is not available on this site.

02/09/1994 SUPPL-37 Labeling

Label is not available on this site.

04/14/1994 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/11/1991 SUPPL-35 Labeling

Label is not available on this site.

07/06/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/06/1994 SUPPL-33 Labeling

Label is not available on this site.

07/06/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/05/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-30 Labeling

Label is not available on this site.

09/25/1989 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-27 Labeling

Label is not available on this site.

09/25/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/17/1990 SUPPL-23 Labeling

Label is not available on this site.

03/05/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-13 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 213386 AMNEAL
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription Yes 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 208412 STRIDES 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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