Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088149
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.25MG 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
04/28/1983 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
11/26/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/12/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/30/1995 SUPPL-22 Labeling

Label is not available on this site.

04/28/1994 SUPPL-21 Labeling

Label is not available on this site.

04/29/1992 SUPPL-20 Labeling

Label is not available on this site.

09/18/1990 SUPPL-19 Labeling

Label is not available on this site.

01/23/1990 SUPPL-18 Labeling

Label is not available on this site.

07/31/1989 SUPPL-17 Labeling

Label is not available on this site.

09/16/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/01/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/01/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/20/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/07/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/27/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/27/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/27/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/27/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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