Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020225
Company: SCHERING PLOUGH

Products on NDA 020225

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMDUR	ISOSORBIDE MONONITRATE	30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
IMDUR	ISOSORBIDE MONONITRATE	60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
IMDUR	ISOSORBIDE MONONITRATE	120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1993	ORIG-1	Approval	Type 3 - New Dosage Form	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
01/22/2003	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20225slr008ltr.pdf
02/17/1999	SUPPL-7	Labeling		Label is not available on this site.
12/18/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/27/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/17/1997	SUPPL-4	Labeling		Label is not available on this site.
01/23/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/06/1996	SUPPL-2	Labeling		Label is not available on this site.
03/30/1995	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.