FDA.reportPublic FDA data

Application 074862

Type
ANDA
Sponsor
RHODES PHARMS

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
35356-833morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-833morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-836morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-836morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-838Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-838Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
52959-185Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.ANDACurrent
52959-406Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.ANDACurrent
61919-923MORPHINE SULFATEMORPHINE SULFATEDIRECT RXANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDIRECT RXANDACurrent
63629-4483Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4483Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4515morphine sulfatemorphine sulfateBryant Ranch PrepackANDACurrent
63629-4515Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24049ORIG2015-06-30
42888ORIG1999-03-30
18369ORIG1998-07-07
8458ORIG1998-07-07