FDA.reportPublic FDA data

Application 018651

Type
NDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MARINOLDRONABINOLCAPSULE;ORAL2.5MGYesNo
002MARINOLDRONABINOLCAPSULE;ORAL5MGYesYes
003MARINOLDRONABINOLCAPSULE;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0051-0021MarinolDronabinolAbbVie Inc.NDACurrent
0051-0021MarinolDronabinolAbbVie Inc.NDACurrent
0051-0021MarinolDronabinolAbbVie Inc.NDACurrent
0051-0021MarinolDronabinolAbbVie Inc.NDACurrent
0051-0022MarinolDronabinolAbbVie Inc.NDACurrent
0051-0022MarinolDronabinolAbbVie Inc.NDACurrent
0051-0022MarinolDronabinolAbbVie Inc.NDACurrent
0051-0022MarinolDronabinolAbbVie Inc.NDACurrent
0051-0023MarinolDronabinolAbbVie Inc.NDACurrent
0051-0023MarinolDronabinolAbbVie Inc.NDACurrent
0051-0023MarinolDronabinolAbbVie Inc.NDACurrent
0051-0023MarinolDronabinolAbbVie Inc.NDACurrent
0591-3591DronabinolDronabinolActavis Pharma, Inc.NDACurrent
0591-3592DronabinolDronabinolActavis Pharma, Inc.NDACurrent
0591-3593DronabinolDronabinolActavis Pharma, Inc.NDACurrent
0904-7068DronabinolDronabinolMajor PharmaceuticalsNDACurrent
0904-7144DronabinolDronabinolMajor PharmaceuticalsNDACurrent
0904-7144DronabinolDronabinolMajor PharmaceuticalsNDACurrent
0904-7145DronabinolDronabinolMajor PharmaceuticalsNDACurrent
0904-7145DronabinolDronabinolMajor PharmaceuticalsNDACurrent
53097-568MarinolDronabinolThePharmaNetwork, LLCNDACurrent
53097-569MarinolDronabinolThePharmaNetwork, LLCNDACurrent
53097-570MarinolDronabinolThePharmaNetwork, LLCNDACurrent
53097-571MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
53097-571MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
53097-572MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
53097-572MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
53097-573MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
53097-573MARINOLDronabinolThePharmaNetwork, LLCNDACurrent
63629-8861DronabinolDronabinolBryant Ranch PrepackNDACurrent
63629-8861DronabinolDronabinolBryant Ranch PrepackNDACurrent
63629-8862DronabinolDronabinolBryant Ranch PrepackNDACurrent
63629-8862DronabinolDronabinolBryant Ranch PrepackNDACurrent
63629-9166DronabinolDronabinolBryant Ranch PrepackNDACurrent
63629-9166DronabinolDronabinolBryant Ranch PrepackNDACurrent
67877-568DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-568DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-568DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-569DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-569DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-569DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-570DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-570DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-570DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-753DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-753DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-753DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-754DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-754DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-754DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-755DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-755DronabinolDronabinolAscend Laboratories, LLCNDACurrent
67877-755DronabinolDronabinolAscend Laboratories, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85542SUPPL 2026-03-27
85541SUPPL 2026-03-27
73247SUPPL2023-01-18
73239SUPPL2023-01-18
57615ORIG2019-02-15
49627SUPPL2017-08-30
49585SUPPL2017-08-30
33540SUPPL2006-06-28
15069SUPPL2006-06-28
11260SUPPL2006-06-28
995SUPPL2006-06-28
11259SUPPL2005-04-28
994SUPPL2005-04-28
993SUPPL2003-05-29
11258SUPPL2003-05-06
45040SUPPL2000-09-22
20142SUPPL1999-08-05