Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211951
Company: PADAGIS ISRAEL

Products on ANDA 211951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211951

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211951Orig1s000TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211951Orig1s003ltr.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NALOXONE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 4MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	217992	AMNEAL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	211951	PADAGIS ISRAEL
NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	208411	EMERGENT