Application 018651

Type: NDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MARINOL	DRONABINOL	CAPSULE;ORAL	2.5MG	Yes	No
002	MARINOL	DRONABINOL	CAPSULE;ORAL	5MG	Yes	Yes
003	MARINOL	DRONABINOL	CAPSULE;ORAL	10MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018651-001	MARINOL	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31
N018651-002	MARINOL	DRONABINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31
N018651-003	MARINOL	DRONABINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018651-001	AB
N018651-002	AB
N018651-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018651-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dronabinol	DRONABINOL	Major Pharmaceuticals	fd8c5d57-0173-4f62-8ff0-d8147986a976	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651 ndc (product): 0904-7145 ndc (product): 0904-7144
Dronabinol	DRONABINOL	Ascend Laboratories, LLC	adb1801c-0fb5-4e16-b969-1db91230e0b9	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651 ndc (product): 67877-753 ndc (product): 67877-754 ndc (product): 67877-755
MARINOL	DRONABINOL	ThePharmaNetwork, LLC	d0efeeec-640d-43c3-8f0a-d31324a11c68	2023-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651 ndc (product): 53097-571 ndc (product): 53097-572 ndc (product): 53097-573
Marinol	DRONABINOL	ThePharmaNetwork, LLC	628f9609-6583-49be-be77-b64cfbc46fd7	2019-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651 ndc (product): 53097-569 ndc (product): 53097-568 ndc (product): 53097-570

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0051-0021	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0021	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0021	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0021	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0022	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0022	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0022	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0022	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0023	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0023	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0023	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0051-0023	Marinol	Dronabinol	AbbVie Inc.	NDA	Current
0591-3591	Dronabinol	Dronabinol	Actavis Pharma, Inc.	NDA	Current
0591-3592	Dronabinol	Dronabinol	Actavis Pharma, Inc.	NDA	Current
0591-3593	Dronabinol	Dronabinol	Actavis Pharma, Inc.	NDA	Current
0904-7068	Dronabinol	Dronabinol	Major Pharmaceuticals	NDA	Current
0904-7144	Dronabinol	Dronabinol	Major Pharmaceuticals	NDA	Current
0904-7144	Dronabinol	Dronabinol	Major Pharmaceuticals	NDA	Current
0904-7145	Dronabinol	Dronabinol	Major Pharmaceuticals	NDA	Current
0904-7145	Dronabinol	Dronabinol	Major Pharmaceuticals	NDA	Current
53097-568	Marinol	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-569	Marinol	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-570	Marinol	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-571	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-571	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-572	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-572	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-573	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
53097-573	MARINOL	Dronabinol	ThePharmaNetwork, LLC	NDA	Current
63629-8861	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
63629-8861	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
63629-8862	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
63629-8862	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
63629-9166	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
63629-9166	Dronabinol	Dronabinol	Bryant Ranch Prepack	NDA	Current
67877-568	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-568	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-568	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-569	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-569	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-569	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-570	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-570	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-570	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-753	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-753	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-753	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-754	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-754	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-754	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-755	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-755	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current
67877-755	Dronabinol	Dronabinol	Ascend Laboratories, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85542	SUPPL	2026-03-27
85541	SUPPL	2026-03-27
73247	SUPPL	2023-01-18
73239	SUPPL	2023-01-18
57615	ORIG	2019-02-15
49627	SUPPL	2017-08-30
49585	SUPPL	2017-08-30
33540	SUPPL	2006-06-28
15069	SUPPL	2006-06-28
11260	SUPPL	2006-06-28
995	SUPPL	2006-06-28
11259	SUPPL	2005-04-28
994	SUPPL	2005-04-28
993	SUPPL	2003-05-29
11258	SUPPL	2003-05-06
45040	SUPPL	2000-09-22
20142	SUPPL	1999-08-05