Drugs@FDA: FDA-Approved Drugs
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| NORCURON | VECURONIUM BROMIDE | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| NORCURON | VECURONIUM BROMIDE | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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. |
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| 12/17/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |