Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087801
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/1982 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
11/24/2008 SUPPL-31 Labeling

Label is not available on this site.

08/28/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-21 Labeling

Label is not available on this site.

06/09/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/09/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-16 Labeling

Label is not available on this site.

10/07/1994 SUPPL-15 Labeling

Label is not available on this site.

03/30/1994 SUPPL-14 Labeling

Label is not available on this site.

06/05/1991 SUPPL-13 Labeling

Label is not available on this site.

12/28/1989 SUPPL-11 Labeling

Label is not available on this site.

11/21/1989 SUPPL-10 Labeling

Label is not available on this site.

03/28/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/28/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 040581 VINTAGE PHARMS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 087801 WEST-WARD PHARMS INT

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