Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017598
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SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No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SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No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.

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

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