FDA.reportPublic FDA data

Application 203602

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
003MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
004MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL100MGNoNo
005MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-540Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-540Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-541Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-541Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-542Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-542Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-543Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-543Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-544Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
40032-544Morphine SulfateMorphine SulfateNovel Laboratories, Inc.ANDACurrent
43386-540Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-540Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-541Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-541Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-542Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-542Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-543Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-543Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-544Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-544Morphine SulfateMorphine SulfateLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76292ORIG 2023-11-03
32453ORIG2015-12-18