Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019915
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONOPRIL FOSINOPRIL SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MONOPRIL FOSINOPRIL SODIUM 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MONOPRIL FOSINOPRIL SODIUM 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
05/16/1991 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/09/2009 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008ltr.pdf
10/29/2003 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr006ltr.pdf
05/27/2003 SUPPL-37 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19915se5-037_monopril_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915se5-037ltr.pdf
09/21/2000 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-32 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19915slr032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-915S032.pdf
11/16/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/24/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/21/1999 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/11/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/28/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/12/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/21/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/08/1997 SUPPL-21 Labeling

Label is not available on this site.

08/02/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/20/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/29/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1996 SUPPL-17 Labeling

Label is not available on this site.

03/27/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/28/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/14/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/19/1994 SUPPL-10 Labeling

Label is not available on this site.

05/02/1995 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

04/05/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/07/1992 SUPPL-7 Labeling

Label is not available on this site.

07/10/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/22/1992 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/25/1992 SUPPL-4 Labeling

Label is not available on this site.

09/09/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/27/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/27/2003 SUPPL-37 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19915se5-037_monopril_lbl.pdf

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