FDA.reportPublic FDA data

Application 006134

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL5MGYesYes
004DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDESYRUP;ORAL10MG/30MLNoNo
010DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDIRECT RXNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent
71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent
71335-1106METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67723SUPPL2021-06-07
67675SUPPL2021-06-03
67672SUPPL2021-06-03
60348SUPPL2019-10-08
60301SUPPL2019-10-08
60300SUPPL2019-10-08
55819SUPPL2018-10-05
55818SUPPL2018-10-05
55643SUPPL2018-09-28
55642SUPPL2018-09-28
52282SUPPL2018-02-02
52253SUPPL2018-02-01
48581SUPPL2017-05-31
46275SUPPL2016-12-20
46274SUPPL2016-12-20
46196SUPPL2016-12-19
46195SUPPL2016-12-19
45458SUPPL2016-10-04
28SUPPL2016-04-22
74SUPPL2015-06-29
10682SUPPL2015-04-07
75SUPPL2015-04-03
27SUPPL2014-08-20
26SUPPL2014-04-17
32939SUPPL2014-04-16
25SUPPL2013-04-16
10681SUPPL2012-07-12
44437ORIG2012-07-11
73SUPPL2012-07-11
72SUPPL2012-07-11
43994ORIG2009-08-12
24SUPPL2006-12-04
32938SUPPL2006-11-21
20008SUPPL2006-11-17