Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212955
Company: PURDUE PHARMA LP

Products on ANDA 212955

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212955

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212955Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212955

NALMEFENE HYDROCHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	216007	CHENGDU SHUODE
NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212955	PURDUE PHARMA LP