Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085813
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Discontinued None 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
05/31/1978 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
04/10/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/05/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/03/1989 SUPPL-28 Labeling

Label is not available on this site.

08/12/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/11/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/21/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/21/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/16/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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