Viewing data from:

NALMEFENE HYDROCHLORIDE

ANDA

NALMEFENE HYDROCHLORIDE | A212955 | KNOA PHARMA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCNALMEFENE HYDROCHLORIDE

DMF 156632001

RUSAN PHARMA LTDNALMEFENE HYDROCHLORIDE

DMF 343672019

SICHUAN QINGMU PHARMACEUTICAL CO LTDNALMEFENE HYDROCHLORIDE

DMF 367512022

PURISYS LLCNALMEFENE HYDROCHLORIDE DRUG SUBSTANCE

DMF 397672024

SANOFI SAInactiveNALMEFENE HYDROCHLORIDE

DMF 54841984

NV ORGANONInactiveNALMEFENE HYDROCHLORIDE

DMF 56421984

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveNALMEFENE HYDROCHLORIDE

DMF 85071990

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 4, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Feb 8, 2022

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

KNOA Pharma replaced Purdue Pharma LP as the applicant for nalmefene hydrochloride NDA 212955.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC replaced PURDUE PHARMA LP as the listed applicant for nalmefene hydrochloride (NDA 212955).

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC