Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020984

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20984ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20984_Raplon.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2010	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020984s003ltr.pdf
07/07/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

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