Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
01 3Sichuan Qingmu Pharmaceutical
02 7H. Lundbeck AS
03 2Hikma Pharmaceuticals
04 1Indivior
05 2Purdue Pharmaceuticals L.P
01 3Antic-calc Tablet, Film Coated
02 4Film Coated Tablet
03 6SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
04 1SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
05 1SPRAY;NASAL
01 1Allowed
02 1Approved
03 2Authorized
04 3DISCN
05 4RX
06 4Blank
01 4NALMEFENE HYDROCHLORIDE
02 1OPVEE
03 2REVEX
04 7Selincro
05 1ZURNAI (AUTOINJECTOR)
01 3Norway
02 2Spain
03 1Sweden
04 1Switzerland
05 8USA
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Regulatory Info : RX
Registration Country : USA
Brand Name : NALMEFENE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Packaging :
Approval Date : 2023-11-15
Application Number : 216007
Regulatory Info : RX
Registration Country : USA
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Regulatory Info : RX
Registration Country : USA
Brand Name : NALMEFENE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2023-11-15
Application Number : 216007
Regulatory Info : RX
Registration Country : USA
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Regulatory Info :
Registration Country : USA
Brand Name : NALMEFENE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 2MG BASE/2ML (EQ 1MGBASE/ML)
Packaging :
Approval Date :
Application Number : 216007
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Selincro
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 18 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Selincro
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 18 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Selincro
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 18 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Nalmefene Hydrochloride Dihydrate
Brand Name : Selincro
Dosage Form : Film Coated Tablet
Dosage Strength : 18mg
Packaging :
Approval Date : 25/02/2013
Application Number : 20120120000033
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Selincro
Dosage Form : Film Coated Tablet
Dosage Strength : 186mg
Packaging :
Approval Date : 15/04/2014
Application Number : 62764
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Selincro
Dosage Form : Film Coated Tablet
Dosage Strength : 18MG
Packaging :
Approval Date : 2013-04-30
Application Number : 112815002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Selincro
Dosage Form : Film Coated Tablet
Dosage Strength : 18MG
Packaging :
Approval Date : 2024-11-20
Application Number : 112815002IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : DISCN
Registration Country : USA
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**
Packaging :
Approval Date : 1995-04-17
Application Number : 20459
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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**
Packaging :
Approval Date : 1995-04-17
Application Number : 20459
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OPVEE
Dosage Form : SPRAY;NASAL
Dosage Strength : EQ 2.7MG BASE/SPRAY
Packaging :
Approval Date : 2023-05-22
Application Number : 217470
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : NALMEFENE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2022-02-08
Application Number : 212955
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZURNAI (AUTOINJECTOR)
Dosage Form : SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
Dosage Strength : EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Packaging :
Approval Date : 2024-08-07
Application Number : 218590
Regulatory Info : DISCN
Registration Country : USA
