Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078717
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/2008 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078717s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078717s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2019 | SUPPL-23 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/26/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2012 | SUPPL-11 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/26/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078717s000lbl.pdf |