Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087014
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORGATRAX | HYDROXYZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ORGATRAX | HYDROXYZINE HYDROCHLORIDE | 50MG/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 |
|---|---|---|---|---|---|---|---|
| 06/27/1980 | 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 |
|---|---|---|---|---|---|
| 11/28/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/26/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/23/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/23/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |