U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075305
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription AO 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
09/28/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75305ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75305_Haloperidol%20Decanoate.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2023 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/18/2019 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

01/29/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/19/2008 SUPPL-12 Labeling

Label is not available on this site.

06/18/2008 SUPPL-11 Labeling

Label is not available on this site.

02/04/2008 SUPPL-10 Labeling

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/16/2001 SUPPL-1 Labeling

Label is not available on this site.

HALOPERIDOL DECANOATE

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
Back to Top