Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085161
Company: WATSON LABS
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
11/11/1976 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-57 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1998 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/15/1997 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-52 Labeling

Label is not available on this site.

02/08/1994 SUPPL-51 Labeling

Label is not available on this site.

01/28/1991 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/09/1988 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/09/1988 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/04/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/11/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/22/1983 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-29 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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