Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074893
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription AO No No
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
12/19/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2016 SUPPL-19 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/22/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/14/2009 SUPPL-13 Labeling

Label is not available on this site.

10/30/2008 SUPPL-12 Labeling

Label is not available on this site.

12/05/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

11/19/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HALOPERIDOL DECANOATE

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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