FDA.reportPublic FDA data

Application 203326

Type
ANDA
Sponsor
HIKMA

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
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateWest-Ward Pharmaceuticals CorpANDACurrent
0904-7009buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateMajor PharmaceuticalsANDACurrent
0904-7009buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateMajor PharmaceuticalsANDACurrent
0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateMajor PharmaceuticalsANDACurrent
0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateMajor PharmaceuticalsANDACurrent
0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateMajor PharmaceuticalsANDACurrent
71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent
71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent
71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent
71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent
71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent
71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44588ORIG2015-07-02