Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085162
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 10MG 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
11/12/1976 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
04/25/2001 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/16/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-41 Labeling

Label is not available on this site.

02/08/1994 SUPPL-40 Labeling

Label is not available on this site.

01/28/1991 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/29/1984 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/16/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/22/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 084122 HIKMA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 088832 MYLAN
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 085162 WATSON LABS

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