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Approved Drug Products containing Nalmefene listed in the FDA Orange Book. Original Data : FDA Website

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NALMEFENE HYDROCHLORIDE

Brand Name : REVEX

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-04-17

Application Number : 20459

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

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NALMEFENE HYDROCHLORIDE

Brand Name : REVEX

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-04-17

Application Number : 20459

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

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NALMEFENE HYDROCHLORIDE

Brand Name : OPVEE

Dosage Form : SPRAY;NASAL

Dosage Strength : EQ 2.7MG BASE/SPRAY

Approval Date : 2023-05-22

Application Number : 217470

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

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NALMEFENE HYDROCHLORIDE

Brand Name : NALMEFENE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

Approval Date : 2022-02-08

Application Number : 212955

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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NALMEFENE HYDROCHLORIDE

Brand Name : ZURNAI (AUTOINJECTOR)

Dosage Form : SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

Dosage Strength : EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)

Approval Date : 2024-08-07

Application Number : 218590

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

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NALMEFENE HYDROCHLORIDE

Brand Name : NALMEFENE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date : 2023-11-15

Application Number : 216007

RX/OTC/DISCN : RX

RLD : No

TE Code :

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07

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NALMEFENE HYDROCHLORIDE

Brand Name : NALMEFENE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

Approval Date : 2023-11-15

Application Number : 216007

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

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NALMEFENE HYDROCHLORIDE

Brand Name : NALMEFENE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 2MG BASE/2ML (EQ 1MGBASE/ML)

Approval Date :

Application Number : 216007

RX/OTC/DISCN :

RLD :

TE Code :

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