Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010155
Company: SANOFI AVENTIS US

Products on NDA 10155

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYTELASE	AMBENONIUM CHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 010155

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf
11/14/2011	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf
11/14/2011	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s022lbl.pdf