Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084084
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG 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
07/10/1974 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
12/01/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/23/1991 SUPPL-20 Labeling

Label is not available on this site.

03/15/1991 SUPPL-19 Labeling

Label is not available on this site.

04/05/1990 SUPPL-18 Labeling

Label is not available on this site.

03/20/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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