Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012093
Company: BAUSCH

Products on NDA 12093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISORDIL	ISOSORBIDE DINITRATE	40MG	TABLET;ORAL	Prescription	AB	Yes	Yes
ISORDIL	ISOSORBIDE DINITRATE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ISORDIL	ISOSORBIDE DINITRATE	30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ISORDIL	ISOSORBIDE DINITRATE	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ISORDIL	ISOSORBIDE DINITRATE	5MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 012093

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2015	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf