FdaApplication

ANDA 207000

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Identifiers

Properties

PropertyValue
applicant_nameSPECGX LLC
application_typeANDA
approval_date2017-12-13

Products (2)

ProductActive ingredientStrengthDosage form
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET;SUBLINGUAL

2 products