Drugs@FDA: FDA Approved Drug Products

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

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

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