Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075218
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | 20MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/23/1999 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2018 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |