Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088254
Company: PHARMOBEDIENT CNSLTG

Products on ANDA 088254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	ELIXIR;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/1983	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
06/05/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/06/2015	SUPPL-15	Labeling		Label is not available on this site.
02/03/1995	SUPPL-13	Labeling		Label is not available on this site.
12/23/1993	SUPPL-12	Labeling		Label is not available on this site.
12/23/1993	SUPPL-11	Labeling		Label is not available on this site.
12/31/1990	SUPPL-10	Labeling		Label is not available on this site.
12/06/1989	SUPPL-9	Labeling		Label is not available on this site.
05/18/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/18/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/22/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/08/1984	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/22/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/01/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.