Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020225
Company: SCHERING PLOUGH
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IMDUR ISOSORBIDE MONONITRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
IMDUR ISOSORBIDE MONONITRATE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
IMDUR ISOSORBIDE MONONITRATE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
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.

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