Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012093
Company: BAUSCH
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ISORDIL ISOSORBIDE DINITRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ISORDIL ISOSORBIDE DINITRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ISORDIL ISOSORBIDE DINITRATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ISORDIL ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription AB 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
11/09/1959 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2015 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012093Orig1s052ltr.pdf
11/20/2014 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

09/26/2001 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12093s44ltr.pdf
06/16/1999 SUPPL-43 Labeling

Label is not available on this site.

10/16/1991 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/11/1995 SUPPL-41 Labeling

Label is not available on this site.

07/29/1988 SUPPL-37 Labeling

Label is not available on this site.

02/16/1989 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

ISORDIL

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISORDIL ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription Yes AB 012093 BAUSCH
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription No AB 213057 ZYDUS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISORDIL ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription Yes AB 012093 BAUSCH
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086067 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086923 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086221 SANDOZ
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 213057 ZYDUS

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