Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078764
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/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 |
|---|---|---|---|---|---|---|---|
| 01/30/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |