Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075147
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET;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
11/27/1998 ORIG-1 Approval Label
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2000 SUPPL-3 Labeling

Label is not available on this site.

03/20/2000 SUPPL-2 Labeling

Label is not available on this site.

09/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/1998 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm

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