Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075393
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| 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 |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 05/11/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75393ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75393_Haloperidol.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/23/2021 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2020 | SUPPL-33 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2019 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2019 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2019 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2012 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/13/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/30/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |