Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088306
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription BP 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
09/15/1983 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
12/01/2008 SUPPL-27 Labeling

Label is not available on this site.

07/14/2005 SUPPL-26 Labeling

Label is not available on this site.

08/28/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-18 Labeling

Label is not available on this site.

05/31/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-16 Labeling

Label is not available on this site.

02/08/1994 SUPPL-15 Labeling

Label is not available on this site.

01/06/1992 SUPPL-14 Labeling

Label is not available on this site.

12/06/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/06/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/09/1992 SUPPL-11 Labeling

Label is not available on this site.

01/24/1990 SUPPL-10 Labeling

Label is not available on this site.

12/06/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/23/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/17/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

There are no Therapeutic Equivalents.

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