Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075041
Company: ALKERMES GAINESVILLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No 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
09/22/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/10/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf

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