FDA.reportPublic FDA data

Application 212451

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL15MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-905MORPHINE SULFATEMORPHINE SULFATEQuality Care Products, LLCANDACurrent
55700-905MORPHINE SULFATEMORPHINE SULFATEQuality Care Products, LLCANDACurrent
55700-905MORPHINE SULFATEMORPHINE SULFATEQuality Care Products, LLCANDACurrent
60687-617MORPHINE SULFATEMORPHINE SULFATEAmerican Health PackagingANDACurrent
60687-617Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
63629-8459MORPHINE SULFATEMORPHINE SULFATEBryant Ranch PrepackANDACurrent
63629-8459MORPHINE SULFATEMORPHINE SULFATEBryant Ranch PrepackANDACurrent
63629-8460MORPHINE SULFATEMORPHINE SULFATEBryant Ranch PrepackANDACurrent
63629-8460MORPHINE SULFATEMORPHINE SULFATEBryant Ranch PrepackANDACurrent
67877-670MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent
67877-670MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent
67877-670MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent
67877-671MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent
67877-671MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent
67877-671MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76467ORIG 2023-11-07
65854ORIG2021-01-07