Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088306
Company: HIKMA

Products on ANDA 088306

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET;ORAL	Prescription	BP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088306

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
09/30/2021	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 088306

DEXAMETHASONE

There are no Therapeutic Equivalents.