Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080356
Company: WATSON LABS
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
01/17/1972 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
04/25/2001 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/15/1998 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

06/16/1997 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-72 Labeling

Label is not available on this site.

02/08/1994 SUPPL-71 Labeling

Label is not available on this site.

01/28/1991 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

10/09/1987 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/08/1987 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/03/1985 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

06/03/1985 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

12/15/1983 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/23/1983 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/20/1983 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/20/1983 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/30/1972 SUPPL-1 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 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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