Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012940
Company: BIOVAIL

Products on NDA 012940

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISORDIL	ISOSORBIDE DINITRATE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ISORDIL	ISOSORBIDE DINITRATE	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ISORDIL	ISOSORBIDE DINITRATE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012940

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1961	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2001	SUPPL-44	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12940s44ltr.pdf
06/16/1999	SUPPL-43	Labeling		Label is not available on this site.
01/11/1995	SUPPL-42	Labeling		Label is not available on this site.
10/16/1991	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
07/29/1988	SUPPL-37	Labeling		Label is not available on this site.
02/16/1989	SUPPL-35	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/29/1988	SUPPL-32	Manufacturing (CMC)-Formulation		Label is not available on this site.