Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 012731
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECASPRAY DEXAMETHASONE 0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AEROSOL;TOPICAL Discontinued None Yes No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
03/29/1961 ORIG-1 Approval Type 3 - New Dosage Form 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
11/29/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/05/1984 SUPPL-11 Labeling

Label is not available on this site.

09/24/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/02/1979 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English