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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020214
Company: ORGANON USA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEMURON ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
ZEMURON ROCURONIUM BROMIDE 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
ZEMURON ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
03/17/1994 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/2018 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020214Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020214Orig1s038Ltr.pdf
01/06/2015 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020214s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020214Orig1s036ltr.pdf
04/29/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
11/22/2010 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020214s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020214s034ltr.pdf
08/28/2008 SUPPL-30 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020214s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020214s030ltr.pdf
08/18/2004 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214s021ltr.pdf
06/04/2003 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20214slr017ltr.pdf
02/06/2004 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214slr016ltr.pdf
07/20/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
06/05/2001 SUPPL-13 Labeling

Label is not available on this site.
03/27/2000 SUPPL-10 Labeling

Label is not available on this site.
03/17/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
03/27/2000 SUPPL-8 Labeling

Label is not available on this site.
06/30/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/03/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
07/25/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
06/21/1996 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/07/1994 SUPPL-3 Labeling

Label is not available on this site.
10/04/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
11/22/1994 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
07/26/2018 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020214Orig1s038lbl.pdf
07/26/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020214Orig1s038lbl.pdf
01/06/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020214s036lbl.pdf
11/22/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020214s034lbl.pdf
08/28/2008 SUPPL-30 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020214s030lbl.pdf
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