Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015923
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
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
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
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
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

HALDOL

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 015923 JANSSEN PHARMS
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204849 AKORN
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075689 FRESENIUS KABI USA
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210356 FRESENIUS KABI USA
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076774 GLAND PHARMA LTD
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078347 MYLAN LABS LTD
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091637 SAGENT PHARMS
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200742 SAGENT PHARMS
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076035 TEVA PHARMS USA
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075858 WEST-WARD PHARMS INT

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