Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020984
Company: ORGANON USA INC

Products on NDA 20984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAPLON	RAPACURONIUM BROMIDE	100MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
RAPLON	RAPACURONIUM BROMIDE	200MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 020984

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2010	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf
08/18/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf