Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084204
Company: SUN PHARM INDUSTRIES

Products on ANDA 084204

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	2.5MG	TABLET;SUBLINGUAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/1978	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-38	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
03/16/1992	SUPPL-35	Labeling		Label is not available on this site.
04/03/1992	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
12/19/1991	SUPPL-31	Labeling		Label is not available on this site.
07/25/1990	SUPPL-30	Labeling		Label is not available on this site.
03/25/1987	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
06/17/1987	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
09/18/1986	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/18/1986	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/13/1984	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/08/1984	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/24/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.