Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086225
Company: SANDOZ

Products on ANDA 086225

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 086225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/1988	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
03/20/1995	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
05/21/1991	SUPPL-27	Labeling		Label is not available on this site.
02/06/1990	SUPPL-26	Labeling		Label is not available on this site.
11/03/1989	SUPPL-25	Labeling		Label is not available on this site.
06/13/1989	SUPPL-24	Labeling		Label is not available on this site.
04/29/1987	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/29/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/29/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/14/1986	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/09/1984	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/29/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/29/1983	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/29/1983	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/29/1983	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/29/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.