Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015923
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/18/1971 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2020 | SUPPL-98 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/015923s093s098,018701s071s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/015923Orig1s093,s098;018701Orig1s071,s076ltr.pdf | |
| 02/23/2017 | SUPPL-96 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s096,018701s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/015923Orig1s096,018701Orig1s074ltr.pdf | |
| 03/08/2019 | SUPPL-95 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/015923s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/015923Orig1s095, 018701Orig1s073ltr.pdf | |
| 05/18/2016 | SUPPL-94 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf | |
| 11/17/2020 | SUPPL-93 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/015923Orig1s093,s098;018701Orig1s071,s076ltr.pdf |
| 12/05/2017 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/015923s092ltr.pdf | |
| 05/26/2015 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/015923Orig1s091ltr.pdf | |
| 05/06/2013 | SUPPL-89 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf |
| 03/01/2011 | SUPPL-86 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf | |
| 12/01/2010 | SUPPL-85 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/015923s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf | |
| 07/19/2009 | SUPPL-84 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf | |
| 08/14/2008 | SUPPL-82 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf | |
| 05/13/2008 | SUPPL-81 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf | |
| 09/19/2007 | SUPPL-80 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf |
| 08/12/2011 | SUPPL-79 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf | |
| 05/04/2007 | SUPPL-78 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf | |
| 12/10/2002 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2002 | SUPPL-72 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/015923_S072_HALDOL_TABLETS_AP.pdf |
| 11/07/2000 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/2000 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2000 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1994 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1990 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1990 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/02/1988 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1988 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1988 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1988 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1988 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1984 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/11/1983 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/20/1981 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/02/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/03/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2020 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/015923s093s098,018701s071s076lbl.pdf | |
| 03/08/2019 | SUPPL-95 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/015923s095lbl.pdf | |
| 12/05/2017 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s092lbl.pdf | |
| 02/23/2017 | SUPPL-96 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s096,018701s074lbl.pdf | |
| 05/18/2016 | SUPPL-94 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf | |
| 05/26/2015 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf | |
| 08/12/2011 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf | |
| 03/01/2011 | SUPPL-86 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf | |
| 12/01/2010 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/015923s085lbl.pdf | |
| 07/19/2009 | SUPPL-84 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf | |
| 08/14/2008 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf | |
| 05/13/2008 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf | |
| 05/04/2007 | SUPPL-78 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf |