Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084122
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 10MG 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
05/17/1974 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-48 Labeling

Label is not available on this site.

02/13/2003 SUPPL-42 Labeling

Label is not available on this site.

08/28/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-35 Labeling

Label is not available on this site.

06/09/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-33 Labeling

Label is not available on this site.

10/07/1994 SUPPL-32 Labeling

Label is not available on this site.

03/30/1994 SUPPL-31 Labeling

Label is not available on this site.

06/05/1991 SUPPL-30 Labeling

Label is not available on this site.

01/01/1990 SUPPL-28 Labeling

Label is not available on this site.

10/13/1989 SUPPL-27 Labeling

Label is not available on this site.

09/21/1989 SUPPL-26 Labeling

Label is not available on this site.

10/15/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/22/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/31/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 088832 MYLAN
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 085162 WATSON LABS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 084122 WEST-WARD PHARMS INT

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