Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012940
Company: BIOVAIL
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ISORDIL ISOSORBIDE DINITRATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ISORDIL ISOSORBIDE DINITRATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ISORDIL ISOSORBIDE DINITRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None Yes No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
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.

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