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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075305
Company: HIKMA

Products on ANDA 075305

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075305

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.

Therapeutic Equivalents for ANDA 075305

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	219168	CAPLIN
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
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

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