FDA.reportPublic FDA data

Application 205509

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL10MG/5MLNoNo
002MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL20MG/5MLNoNo
003MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-1170Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-1170Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.ANDACurrent
62559-170Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-170Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-170Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-170Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-170Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-171Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-171Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-171Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-171Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-171Morphine SulfateMorphine SulfateANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76050ORIG 2023-11-02
53766ORIG2018-04-20