FDA.report

Application 203849

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Related Records

Application Products

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

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

DocumentTitleSubmission typeSubmission no.DateStorage
24118REMSORIG12015-06-30Cached in FDA.report object storage
194950ORIG12015-04-14Cached in FDA.report object storage
102530ORIG12015-04-08Cached in FDA.report object storage