Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088703
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 5MG/5ML SOLUTION;ORAL Prescription None 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
11/08/1984 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
11/27/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2002 SUPPL-24 Labeling

Label is not available on this site.

12/01/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/15/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/15/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-17 Labeling

Label is not available on this site.

12/13/1996 SUPPL-16 Labeling

Label is not available on this site.

12/13/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-14 Labeling

Label is not available on this site.

10/07/1994 SUPPL-13 Labeling

Label is not available on this site.

03/30/1994 SUPPL-12 Labeling

Label is not available on this site.

06/05/1991 SUPPL-11 Labeling

Label is not available on this site.

06/15/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/21/1990 SUPPL-9 Labeling

Label is not available on this site.

10/13/1989 SUPPL-8 Labeling

Label is not available on this site.

05/11/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/1988 SUPPL-4 Labeling

Label is not available on this site.

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