Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040010
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/1994 | 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 |
|---|---|---|---|---|---|
| 11/08/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040010Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040010Orig1s008ltr.pdf | |
| 08/01/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/03/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040010Orig1s008lbl.pdf |