Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074419
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZATHIOPRINE SODIUM | AZATHIOPRINE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/31/1995 | 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 |
|---|---|---|---|---|---|
| 01/07/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/18/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |