FDA.reportPublic FDA data

Application 204393

Type
ANDA
Sponsor
PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MITIGOMORPHINE SULFATEINJECTABLE;INJECTION10MG/MLNoNo
002MITIGOMORPHINE SULFATEINJECTABLE;INJECTION25MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-160MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent
66794-162MITIGOMorphine SulfatePiramal Critical Care, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55231ORIG2018-08-20