Application 207270

Type
ANDA
Sponsor
MAYNE PHARMA INC

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
51862-615Morphine SulfateMorphine SulfateMayne Pharma IncANDACurrent
51862-617Morphine SulfateMorphine SulfateMayne Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76482ORIG 2023-11-07