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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018452
Company: MONARCH PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No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
06/23/1981 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
03/11/2008 SUPPL-25 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
02/14/1997 SUPPL-24 Labeling

Label is not available on this site.
07/12/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
03/19/1997 SUPPL-22 Labeling

Label is not available on this site.
09/11/1996 SUPPL-21 Labeling

Label is not available on this site.
03/16/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
02/22/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
08/21/1992 SUPPL-18 Labeling

Label is not available on this site.
12/01/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/19/1997 SUPPL-16 Labeling

Label is not available on this site.
07/09/1990 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/06/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
03/19/1997 SUPPL-13 Labeling

Label is not available on this site.
03/19/1997 SUPPL-12 Labeling

Label is not available on this site.
03/13/2009 SUPPL-11 Labeling

Label is not available on this site.
11/02/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
04/22/1987 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
11/09/1990 SUPPL-8 Labeling

Label is not available on this site.
08/11/1987 SUPPL-7 Labeling

Label is not available on this site.
03/14/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
06/01/1984 SUPPL-5 Labeling

Label is not available on this site.
05/16/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/13/2009 SUPPL-3 Efficacy-New Indication

Label is not available on this site.
11/01/1984 SUPPL-2 Labeling

Label is not available on this site.
09/16/1982 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
03/11/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf
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