Drugs@FDA: FDA-Approved Drugs
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ZEMURON | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ZEMURON | ROCURONIUM BROMIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |