FDA.reportPublic FDA data

Application 200411

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL20MGNoNo
002MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo
003MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL50MGNoNo
004MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL60MGNoNo
005MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL80MGNoNo
006MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo
007MORPHINE SULFATEMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1277Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1277Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1277Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1277Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1277Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1277Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1278Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1279Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1280Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1281Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1282Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEImpax GenericsANDACurrent
0115-1479Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24094ORIG2016-04-18