Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018701
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
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
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
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 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 075393 TEVA PHARMS USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 074811 WEST-WARD PHARMS INT
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 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 075393 TEVA PHARMS USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075305 WEST-WARD PHARMS INT
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 211180 ZYDUS PHARMS

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