FDA.reportPublic FDA data

Application 022207

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL15MGYesNo
002MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0235Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals CorpNDACurrent
0054-0235Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals CorpNDACurrent
0054-0235Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0236Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0236Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals CorpNDACurrent
0054-0236Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals CorpNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
49999-848Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-413MORPHINE SULFATEMORPHINE SULFATEDIRECTRXNDACurrent
63629-3789Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-3789Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-3789Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-3789Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-4175Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-4175Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
63629-4175Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent
66336-502Morphine SulfateMorphine SulfateDispensing Solutions, Inc.NDACurrent
67296-1522Morphine SulfateMorphine SulfateRedPharm Drug, Inc.NDACurrent
67296-1522Morphine SulfateMorphine SulfateRedPharm Drug, Inc.NDACurrent
67296-1522Morphine SulfateMorphine SulfateRedPharm Drug, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84668SUPPL 2026-01-06
84609SUPPL 2025-12-31
80073SUPPL 2024-11-04
77008SUPPL 2023-12-19
76926SUPPL 2023-12-18
76925SUPPL 2023-12-18
76236ORIG 2023-11-03
67695SUPPL2021-06-03
67694SUPPL2021-06-03
67693SUPPL2021-06-03
66603SUPPL2021-03-08
66602SUPPL2021-03-08
66556SUPPL2021-03-05
60498SUPPL2019-10-09
60382SUPPL2019-10-08
60364SUPPL2019-10-08
55779SUPPL2018-10-01
55778SUPPL2018-10-01
55698SUPPL2018-10-01
55697SUPPL2018-10-01
46346SUPPL2016-12-21
46296SUPPL2016-12-20
7052SUPPL2012-01-25
38387SUPPL2012-01-23
7051SUPPL2010-04-21
42452ORIG2009-04-01
24260ORIG2009-04-01
38386ORIG2008-03-24
29409ORIG2008-03-19