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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084990
Company: SOLVAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXONE 1.5 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
12/18/1975 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
05/16/1996 SUPPL-23 Labeling

Label is not available on this site.

05/05/1994 SUPPL-22 Labeling

Label is not available on this site.

05/05/1994 SUPPL-21 Labeling

Label is not available on this site.

10/30/1992 SUPPL-20 Labeling

Label is not available on this site.

09/22/1992 SUPPL-18 Labeling

Label is not available on this site.

04/24/1992 SUPPL-17 Labeling

Label is not available on this site.

05/15/1991 SUPPL-15 Labeling

Label is not available on this site.

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