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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215964
Company: PAR STERILE PRODUCTS

Products on ANDA 215964

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215964

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2022	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
10/05/2023	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
05/16/2023	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 215964

NALOXONE HYDROCHLORIDE

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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