Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076035
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG 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 |
|---|---|---|---|---|---|---|---|
| 08/29/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76035.ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/08/2018 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/08/2018 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |