FDA.reportPublic FDA data

Application 206573

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL100MG/5MLNoNo
002MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPharmaceutical Associates, Inc.ANDACurrent
0121-0825Morphine SulfateMORPHINE SULFATEPAIANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76143ORIG 2023-11-03