Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084766
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
03/23/1978 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
12/01/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/28/1991 SUPPL-25 Labeling

Label is not available on this site.

01/23/1991 SUPPL-24 Labeling

Label is not available on this site.

04/02/1990 SUPPL-23 Labeling

Label is not available on this site.

03/20/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/21/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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