FDA.reportPublic FDA data

Application 205022

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc..ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-452Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc..ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
62175-458Buprenorphine and NaloxoneBuprenorphine and NaloxoneLannett Company, Inc.ANDACurrent
70518-2311Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-2311Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-2311Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-2327Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
71335-1296Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1296Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1296Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1378Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1378Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1378Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1378Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76371ORIG 2023-11-06
50044APPL2017-10-12
45495ORIG2016-09-21