Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075448
Company: IVAX SUB TEVA PHARMS
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
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG 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
06/19/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75448ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2007 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

01/10/2007 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

01/10/2007 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/14/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

08/07/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-4 Labeling

Label is not available on this site.

08/07/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/07/2001 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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