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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075393
Company: TEVA PHARMS USA

Products on ANDA 075393

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75393ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75393_Haloperidol.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2021	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
06/25/2020	SUPPL-33	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-32	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
01/05/2016	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
05/01/2012	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/06/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/30/2009	SUPPL-6	Labeling		Label is not available on this site.
06/13/2006	SUPPL-4	Labeling		Label is not available on this site.
07/30/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075393

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	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	075393	TEVA PHARMS USA
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	075393	TEVA PHARMS USA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	211180	ZYDUS PHARMS

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