Drugs@FDA: FDA-Approved Drugs
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| MONOPRIL | FOSINOPRIL SODIUM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MONOPRIL | FOSINOPRIL SODIUM | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MONOPRIL | FOSINOPRIL SODIUM | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |