Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074811
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 01/30/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74811ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/19/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/18/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/04/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |