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FDA ANDA · ANDA212955

NALMEFENE HYDROCHLORIDE

Sponsor: KNOA PHARMA

APPLICATION
ANDA212955
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-08
LATEST ACTION
2022-02-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

NALMEFENE HYDROCHLORIDEPrescription
NALMEFENE HYDROCHLORIDE EQ 2MG BASE/2ML (EQ 1MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2022-02-08UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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