Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014242
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXACORT DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1MG PHOSPHATE/INH AEROSOL;NASAL 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
12/17/1965 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-33 Labeling

Label is not available on this site.

12/07/2007 SUPPL-32 Labeling

Label is not available on this site.

12/07/2007 SUPPL-31 Labeling

Label is not available on this site.

05/03/1994 SUPPL-30 Labeling

Label is not available on this site.

09/11/1991 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-28 Labeling

Label is not available on this site.

12/07/2007 SUPPL-27 Labeling

Label is not available on this site.

12/07/2007 SUPPL-26 Labeling

Label is not available on this site.

05/18/1989 SUPPL-25 Labeling

Label is not available on this site.

12/07/2007 SUPPL-24 Labeling

Label is not available on this site.

12/07/2007 SUPPL-23 Labeling

Label is not available on this site.

12/07/2007 SUPPL-22 Labeling

Label is not available on this site.

12/07/2007 SUPPL-21 Labeling

Label is not available on this site.

11/18/1981 SUPPL-20 Labeling

Label is not available on this site.

12/07/2007 SUPPL-19 Labeling

Label is not available on this site.

08/17/1979 SUPPL-18 Labeling

Label is not available on this site.

08/06/1979 SUPPL-16 Labeling

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

10/19/1978 SUPPL-13 Labeling

Label is not available on this site.

09/12/1977 SUPPL-11 Labeling

Label is not available on this site.

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