Drugs@FDA: FDA-Approved Drugs
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |
| SEPTRA GRAPE | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 05/31/1975 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 09/10/2007 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf | |
| 03/11/2008 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf | |
| 07/28/2005 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf | |
| 02/17/2000 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1997 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1991 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1991 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1990 | SUPPL-28 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/01/1992 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/08/1988 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/12/1986 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/11/1984 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/01/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/27/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/22/1982 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/16/1981 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/26/1977 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-7 | Efficacy |
Label is not available on this site. |
||
| 11/12/1976 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/01/1978 | SUPPL-5 | Efficacy |
Label is not available on this site. |
||
| 12/27/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/01/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/17/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1975 | 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 |
|---|---|---|---|---|---|
| 03/11/2008 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf | |
| 09/10/2007 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf | |
| 07/28/2005 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf |