Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 18452

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SULFAMETHOXAZOLE; TRIMETHOPRIM	80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 018452

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