01 3CHENGDU SHUODE
02 2HIKMA
03 1INDIVIOR
04 2PURDUE PHARMA LP
01 6SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
02 1SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
03 1SPRAY;NASAL
01 2DISCN
02 5RX
03 1Blank
01 4NALMEFENE HYDROCHLORIDE
02 1OPVEE
03 2REVEX
04 1ZURNAI (AUTOINJECTOR)
01 3No
02 4Yes
03 1Blank
RLD : Yes
TE Code :
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Strength : EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : Yes
TE Code :
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Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : Yes
TE Code :
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 :
RLD : No
TE Code : AP
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
RLD : Yes
TE Code :
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 :
RLD : No
TE Code :
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 :
RLD : No
TE Code : AP
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
RLD :
TE Code :
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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