Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087800
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 1MG 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-36 Labeling

Label is not available on this site.

08/28/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-24 Labeling

Label is not available on this site.

06/09/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/09/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-19 Labeling

Label is not available on this site.

10/07/1994 SUPPL-18 Labeling

Label is not available on this site.

03/30/1994 SUPPL-17 Labeling

Label is not available on this site.

05/14/1992 SUPPL-16 Labeling

Label is not available on this site.

06/05/1991 SUPPL-15 Labeling

Label is not available on this site.

12/26/1989 SUPPL-13 Labeling

Label is not available on this site.

10/13/1989 SUPPL-12 Labeling

Label is not available on this site.

05/20/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/28/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/28/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 211496 GENEYORK PHARMS
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 040611 JUBILANT CADISTA
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 040584 VINTAGE PHARMS
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 087800 WEST-WARD PHARMS INT

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