Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084764
Company: SUN PHARM INDUSTRIES

Products on ANDA 084764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	0.25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084764

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/1978	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
12/01/1998	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
06/28/1991	SUPPL-27	Labeling		Label is not available on this site.
01/23/1991	SUPPL-26	Labeling		Label is not available on this site.
04/02/1990	SUPPL-25	Labeling		Label is not available on this site.
08/13/1987	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
08/13/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/20/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/09/1984	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/09/1984	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/16/1983	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/16/1983	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/11/1982	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.