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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216624
Company: ACCORD HLTHCARE

Products on ANDA 216624

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2022	ORIG-1	Approval		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
05/15/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216624

NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION; 0.4MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALOXONE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070299	HIKMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216624	ACCORD HLTHCARE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214785	BAXTER HLTHCARE CORP
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214792	BAXTER HLTHCARE CORP
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212455	EUGIA PHARMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212456	EUGIA PHARMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213573	FRESENIUS KABI USA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212300	HIKMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070172	HOSPIRA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070256	HOSPIRA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070257	HOSPIRA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	218404	MANKIND PHARMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204997	MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205014	MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208871	RISING
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208872	RISING
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207633	SOMERSET THERAPS LLC
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207634	SOMERSET THERAPS LLC

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216624	ACCORD HLTHCARE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216977	BPI LABS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213209	DR REDDYS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213279	EUGIA PHARMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213573	FRESENIUS KABI USA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212300	HIKMA
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	072076	INTL MEDICATION
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213843	MYLAN LABS LTD
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215964	PAR STERILE PRODUCTS

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