Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012882
Company: WYETH AYERST

Products on NDA 012882

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISORDIL	ISOSORBIDE DINITRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ISORDIL	ISOSORBIDE DINITRATE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012882

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/1991	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
07/10/1989	SUPPL-33	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/11/1995	SUPPL-32	Labeling		Label is not available on this site.
07/29/1988	SUPPL-26	Labeling		Label is not available on this site.
06/16/1989	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/16/1989	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/12/1980	SUPPL-15	Manufacturing (CMC)-Formulation		Label is not available on this site.