Tetrahydrocannabinol Oral Capsule

Brand(s)
Marinol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2014-01-01)
Oldest Current Product
1994-08-11
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TETRAHYDROCANNABINOL
FDAOB
ORAL\CAPSULE\DRONABINOL
SPL Active
ORAL\CAPSULE, LIQUID FILLED\DRONABINOL
ORAL\CAPSULE\DRONABINOL
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\DRONABINOL
ORAL\CAPSULE\DRONABINOL

product(s) by strength(s)

tetrahydrocannabinol 10 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913593NDAWatson Laboratories, Inc.1994-08-11DRONABINOLORALCAPSULENDA0186511f1af798-17d5-47d0-b129-21d4aa1eb125

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003788172ANDAMylan Pharmaceuticals Inc.2011-11-01DRONABINOLORALCAPSULE, LIQUID FILLEDANDA07850108adbfd9-789a-4888-a9e2-2a6dac867885
2174780763ANDAAkorn2014-06-20DRONABINOLORALCAPSULEANDA079217a0409d82-a61e-4b9e-8717-ced299ccedb2
3498840869ANDAPar Pharmaceutical Companies, Inc.2008-06-27DRONABINOLORALCAPSULEANDA078292a6269fc3-ca40-444f-8035-d6a391d037e0

tetrahydrocannabinol 2.5 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913591NDAWatson Laboratories, Inc.1994-08-11DRONABINOLORALCAPSULENDA0186511f1af798-17d5-47d0-b129-21d4aa1eb125

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003788170ANDAMylan Pharmaceuticals Inc.2011-11-01DRONABINOLORALCAPSULE, LIQUID FILLEDANDA07850108adbfd9-789a-4888-a9e2-2a6dac867885
2174780761ANDAAkorn2014-06-20DRONABINOLORALCAPSULEANDA079217a0409d82-a61e-4b9e-8717-ced299ccedb2
3498840867ANDAPar Pharmaceutical Companies, Inc.2008-06-27DRONABINOLORALCAPSULEANDA078292a6269fc3-ca40-444f-8035-d6a391d037e0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840174ANDAAmerican Health Packaging2010-09-07DRONABINOLORALCAPSULE498840867ANDA07829268b4168b-5782-4e68-a25a-5b4e4408dbce

tetrahydrocannabinol 5 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913592NDAWatson Laboratories, Inc.2005-06-07DRONABINOLORALCAPSULENDA0186511f1af798-17d5-47d0-b129-21d4aa1eb125

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003788171ANDAMylan Pharmaceuticals Inc.2011-11-01DRONABINOLORALCAPSULE, LIQUID FILLEDANDA07850108adbfd9-789a-4888-a9e2-2a6dac867885
2174780762ANDAAkorn2014-06-20DRONABINOLORALCAPSULEANDA079217a0409d82-a61e-4b9e-8717-ced299ccedb2
3498840868ANDAPar Pharmaceutical Companies, Inc.2008-06-27DRONABINOLORALCAPSULEANDA078292a6269fc3-ca40-444f-8035-d6a391d037e0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685929ANDAPhysicians Total Care, Inc.2008-08-19DRONABINOLORALCAPSULE498840868ANDA0782925050ed63-c6bc-4761-9a81-ef8e5f3f378e
2680840175ANDAAmerican Health Packaging2010-09-23DRONABINOLORALCAPSULE498840868ANDA07829268b4168b-5782-4e68-a25a-5b4e4408dbce

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078292DRONABINOLSVC PHARMA LP2008-06-27ANDA078292_001, ANDA078292_002, ANDA078292_003
2ANDA078501DRONABINOLINSYS THERAPEUTICS INC2011-08-19ANDA078501_001, ANDA078501_002, ANDA078501_003
3ANDA079217DRONABINOLAKORN INC2014-06-20ANDA079217_001, ANDA079217_002, ANDA079217_003
4NDA018651MARINOLABBVIE INC1985-05-31NDA018651_001, NDA018651_002, NDA018651_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078292_001RXDRONABINOL (2.5MG)ORALCAPSULEFalseAB2008-06-27DRONABINOL
2ANDA078292_002RXDRONABINOL (5MG)ORALCAPSULEFalseAB2008-06-27DRONABINOL
3ANDA078292_003RXDRONABINOL (10MG)ORALCAPSULEFalseAB2008-06-27DRONABINOL
4ANDA078501_001RXDRONABINOL (2.5MG)ORALCAPSULEFalseAB2011-08-19DRONABINOL
5ANDA078501_002RXDRONABINOL (5MG)ORALCAPSULEFalseAB2011-08-19DRONABINOL
6ANDA078501_003RXDRONABINOL (10MG)ORALCAPSULEFalseAB2011-08-19DRONABINOL
7ANDA079217_001RXDRONABINOL (2.5MG)ORALCAPSULEFalseAB2014-06-20DRONABINOL
8ANDA079217_002RXDRONABINOL (5MG)ORALCAPSULEFalseAB2014-06-20DRONABINOL
9ANDA079217_003RXDRONABINOL (10MG)ORALCAPSULEFalseAB2014-06-20DRONABINOL
10NDA018651_001RXDRONABINOL (2.5MG)ORALCAPSULEFalseAB1985-05-31MARINOL
11NDA018651_002RXDRONABINOL (5MG)ORALCAPSULETrueAB1985-05-31MARINOL
12NDA018651_003RXDRONABINOL (10MG)ORALCAPSULEFalseAB1985-05-31MARINOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108adbfd9-789a-4888-a9e2-2a6dac867885 (view SPL)DRONABINOL CAPSULES, USP 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-09-153003788170, 003788171, 003788172
21f1af798-17d5-47d0-b129-21d4aa1eb125 (view SPL)Dronabinol CapsulesprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, MANUFACTURE2014-01-015005913591, 005913592, 005913593
35050ed63-c6bc-4761-9a81-ef8e5f3f378e (view SPL)Dronabinol Capsules, USP CIII Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-01-273548685929
45bbac0b1-ddc2-400b-8e0d-1e1d484720ca (view SPL)MARINOL (dronabinol) CapsulesprescriptionHuman PrescriptionAbbvie Inc.2015-08-1216000510021, 000510022, 000510023
568b4168b-5782-4e68-a25a-5b4e4408dbce (view SPL)DRONABINOLprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-293680840174, 680840175
6a0409d82-a61e-4b9e-8717-ced299ccedb2 (view SPL)DronabinolCapsules USPprescriptionHuman PrescriptionAkorn2014-06-262174780761, 174780762, 174780763
7a6269fc3-ca40-444f-8035-d6a391d037e0 (view SPL)Dronabinol Capsules, USP CIII Rx onlyprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2012-01-205498840867, 498840868, 498840869

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII