Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017744
Company: LEGACY

Products on NDA 17744

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOTOFEN	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE	0.025MG;1MG	TABLET;ORAL	Prescription	None	Yes	Yes
MOTOFEN HALF-STRENGTH	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE	0.025MG;0.5MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 017744

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2017	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017744s026lbl.pdf