Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018701
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | Yes |
| HALDOL | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/1986 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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-76 | 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-74 | 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-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018701s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/015923Orig1s095,%20018701Orig1s073ltr.pdf | |
| 05/18/2016 | SUPPL-72 | 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-71 | 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-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018701s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018701s070ltr.pdf | |
| 12/19/2013 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2013 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2013 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2013 | SUPPL-65 | 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-63 | 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-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf | |
| 07/19/2009 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf | |
| 08/14/2008 | SUPPL-57 | 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-56 | 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-55 | 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-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf | |
| 05/04/2007 | SUPPL-53 | 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 | |
| 04/17/2002 | SUPPL-46 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018701_S046_HALDOL_TABLETS_AP.pdf |
| 04/13/2000 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/11/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1995 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/21/1990 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1989 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/10/1989 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1989 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1989 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1989 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
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-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/015923s093s098,018701s071s076lbl.pdf | |
| 03/08/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018701s073lbl.pdf | |
| 12/05/2017 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018701s070lbl.pdf | |
| 02/23/2017 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s096,018701s074lbl.pdf | |
| 05/18/2016 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf | |
| 08/12/2011 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf | |
| 03/01/2011 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf | |
| 12/01/2010 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf | |
| 07/19/2009 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf | |
| 08/14/2008 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf | |
| 05/13/2008 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf | |
| 05/04/2007 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf |
HALDOL
INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 018701 | JANSSEN PHARMS |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 074893 | FRESENIUS KABI USA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 205241 | GLAND PHARMA LTD |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 074811 | HIKMA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 216730 | MANKIND PHARMA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 214507 | MEITHEAL |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 075440 | MYLAN LABS LTD |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 209101 | SOMERSET THERAPS LLC |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 211180 | ZYDUS PHARMS |
INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 018701 | JANSSEN PHARMS |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 074893 | FRESENIUS KABI USA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 205241 | GLAND PHARMA LTD |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 075305 | HIKMA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 216730 | MANKIND PHARMA |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 214507 | MEITHEAL |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 075440 | MYLAN LABS LTD |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 209101 | SOMERSET THERAPS LLC |
| HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AO | 211180 | ZYDUS PHARMS |