FDA.reportPublic FDA data

Application 078292

Type
ANDA
Sponsor
SVC PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DRONABINOLDRONABINOLCAPSULE;ORAL2.5MGNoNo
002DRONABINOLDRONABINOLCAPSULE;ORAL5MGNoNo
003DRONABINOLDRONABINOLCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6597DronabinolDronabinolMajor PharmaceuticalsANDACurrent
0904-6597DronabinolDronabinolMajor PharmaceuticalsANDACurrent
0904-6598DronabinolDronabinolMajor PharmaceuticalsANDACurrent
0904-6745DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6745DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6745DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6745DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6746DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6746DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6746DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
0904-6746DRONABINOLDRONABINOLMajor PharmaceuticalsANDACurrent
42858-867DRONABINOLDRONABINOLRhodes Pharmaceuticals L.P.ANDACurrent
42858-868DRONABINOLDRONABINOLRhodes Pharmaceuticals L.P.ANDACurrent
42858-869DRONABINOLDRONABINOLRhodes Pharmaceuticals L.P.ANDACurrent
49884-867DronabinolDronabinolPar Pharmaceutical, Inc.ANDACurrent
49884-868DronabinolDronabinolPar Pharmaceutical, Inc.ANDACurrent
49884-869DronabinolDronabinolPar Pharmaceutical, Inc.ANDACurrent
60687-375DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
60687-375DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
60687-375DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
60687-386DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
60687-386DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
60687-386DRONABINOLDRONABINOLAmerican Health PackagingANDACurrent
68084-174DronabinolDronabinolAmerican Health PackagingANDACurrent
68084-175DronabinolDronabinolAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9138ORIG2008-07-01