Application 078292

Type: ANDA
Sponsor: SVC PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRONABINOL	DRONABINOL	CAPSULE;ORAL	2.5MG	No	No
002	DRONABINOL	DRONABINOL	CAPSULE;ORAL	5MG	No	No
003	DRONABINOL	DRONABINOL	CAPSULE;ORAL	10MG	No	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	Approval date
A078292-001	DRONABINOL	DRONABINOL	2.5MG	CAPSULE / ORAL	2008-06-27
A078292-002	DRONABINOL	DRONABINOL	5MG	CAPSULE / ORAL	2008-06-27
A078292-003	DRONABINOL	DRONABINOL	10MG	CAPSULE / ORAL	2008-06-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078292-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078292-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078292-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078292-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078292-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078292-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078292-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078292-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078292-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078292-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078292-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078292-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078292-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078292-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078292-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078292-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078292-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078292-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078292-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078292-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078292-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078292-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078292-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078292-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078292-001	AB	1	`c0c555d07b60…`

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 · 9 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	Name fallback brand name: Dronabinol generic name: DRONABINOL
Dronabinol	DRONABINOL	Ascend Laboratories, LLC	adb1801c-0fb5-4e16-b969-1db91230e0b9	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Dronabinol generic name: DRONABINOL
SYNDROS	DRONABINOL	Benuvia Operations, LLC	a7801c70-995d-46a2-91ee-141ef427c6b5	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: DRONABINOL
SYNDROS	DRONABINOL	Wellhouse Pharma, LLC	3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: DRONABINOL
DRONABINOL	DRONABINOL	Camber Pharmaceuticals Inc	66f36fe0-9808-4b73-a99a-794d86ff0c1c	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: DRONABINOL generic name: DRONABINOL
DRONABINOL	DRONABINOL	Wellhouse Pharma, LLC	495aabae-3597-49dc-a5af-e328bcd937b7	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: DRONABINOL generic name: DRONABINOL
Dronabinol	DRONABINOL	Chartwell RX, LLC	44205ae6-b86a-485c-baf6-233a2c878640	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Dronabinol generic name: DRONABINOL
MARINOL	DRONABINOL	ThePharmaNetwork, LLC	d0efeeec-640d-43c3-8f0a-d31324a11c68	2023-02-14	Warnings, Adverse reactions	Name fallback generic name: DRONABINOL
Marinol	DRONABINOL	ThePharmaNetwork, LLC	628f9609-6583-49be-be77-b64cfbc46fd7	2019-04-08	Warnings, Adverse reactions	Name fallback generic name: DRONABINOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6597	Dronabinol	Dronabinol	Major Pharmaceuticals	ANDA	Current
0904-6597	Dronabinol	Dronabinol	Major Pharmaceuticals	ANDA	Current
0904-6598	Dronabinol	Dronabinol	Major Pharmaceuticals	ANDA	Current
0904-6745	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6745	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6745	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6745	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6746	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6746	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6746	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
0904-6746	DRONABINOL	DRONABINOL	Major Pharmaceuticals	ANDA	Current
42858-867	DRONABINOL	DRONABINOL	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-868	DRONABINOL	DRONABINOL	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-869	DRONABINOL	DRONABINOL	Rhodes Pharmaceuticals L.P.	ANDA	Current
49884-867	Dronabinol	Dronabinol	Par Pharmaceutical, Inc.	ANDA	Current
49884-868	Dronabinol	Dronabinol	Par Pharmaceutical, Inc.	ANDA	Current
49884-869	Dronabinol	Dronabinol	Par Pharmaceutical, Inc.	ANDA	Current
60687-375	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
60687-375	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
60687-375	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
60687-386	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
60687-386	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
60687-386	DRONABINOL	DRONABINOL	American Health Packaging	ANDA	Current
68084-174	Dronabinol	Dronabinol	American Health Packaging	ANDA	Current
68084-175	Dronabinol	Dronabinol	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9138	ORIG	2008-07-01