FDA.reportPublic FDA data

Application 203849

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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
0228-4270Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4270Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4270Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4270Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4271Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4271Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4271Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4271Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4311Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4311Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4311Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4311Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4323Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4323Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4323Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4323Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4347Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4347Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4347Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
0228-4347Morphine sulfateMorphine sulfateActavis Pharma, Inc.ANDACurrent
55700-366Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-366Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-366Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-367Morphine sulfateMorphine sulfateLake Erie Medical DBA QuaANDACurrent
55700-367Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-368Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-368Morphine sulfateMorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-701Morphine sulfateMorphine sulfateSt Marys Medical Park PharmacyANDACurrent
60760-702Morphine sulfateMorphine sulfateSt Marys Medical Park PharmacyANDACurrent
67296-1375Morphine sulfateMorphine sulfateRedPharm Drug, Inc.ANDACurrent
67296-1375Morphine sulfateMorphine sulfateRedPharm Drug, Inc.ANDACurrent
67296-1375Morphine sulfateMorphine sulfateRedPharm Drug, Inc.ANDACurrent
71335-0239Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0239Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0239Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0605Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0605Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0628Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent
71335-0628Morphine sulfateMorphine sulfateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24118ORIG2015-06-30
19495ORIG2015-04-14
10253ORIG2015-04-08