Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084763
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 1.5MG 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-27 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/02/1991 SUPPL-21 Labeling

Label is not available on this site.

12/21/1990 SUPPL-20 Labeling

Label is not available on this site.

04/02/1990 SUPPL-19 Labeling

Label is not available on this site.

03/20/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/21/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/24/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/24/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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