Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018776
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORCURON VECURONIUM BROMIDE 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
NORCURON VECURONIUM BROMIDE 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
04/30/1984 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
11/22/2010 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018776s030ltr.pdf
05/19/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18776slr027ltr.pdf
02/02/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2000 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/24/2000 SUPPL-23 Labeling

Label is not available on this site.

06/19/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/10/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/03/1992 SUPPL-16 Labeling

Label is not available on this site.

01/03/1992 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1988 SUPPL-11 Labeling

Label is not available on this site.

02/08/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1987 SUPPL-9 Labeling

Label is not available on this site.

01/28/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1987 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

05/12/1986 SUPPL-6 Labeling

Label is not available on this site.

05/12/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1987 SUPPL-4 Labeling

Label is not available on this site.

01/28/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1984 SUPPL-2 Labeling

Label is not available on this site.

12/17/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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