Application 202067

Type: NDA
Sponsor: LUNDBECK PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONFI	CLOBAZAM	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	ONFI	CLOBAZAM	TABLET;ORAL	10MG	Yes	No
003	ONFI	CLOBAZAM	TABLET;ORAL	20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N202067-001	ONFI	CLOBAZAM	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21
N202067-002	ONFI	CLOBAZAM	10MG	TABLET / ORAL	AB	RLD	2011-10-21
N202067-003	ONFI	CLOBAZAM	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202067-002	AB
N202067-003	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 · 132 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
2026-10-15 13:18:30	2026-09	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202067-002	ONFI	10MG	TABLET / ORAL	AB	RLD	2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202067-003	ONFI	20MG	TABLET / ORAL	AB	RLD, RS	2011-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202067-001	ONFI	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-10-21	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N202067-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202067-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202067-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202067-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202067-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202067-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202067-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202067-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202067-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202067-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202067-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202067-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202067-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202067-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202067-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202067-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202067-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202067-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202067-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202067-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202067-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202067-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202067-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202067-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202067-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202067-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202067-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202067-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202067-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202067-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202067-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202067-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202067-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202067-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202067-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202067-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202067-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202067-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202067-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202067-003	AB	1	`4b0b4de00fa7…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobazam	CLOBAZAM	Sun Pharmaceutical Industries, Inc.	fd1e63bf-496c-427c-83b7-6acabc00a5e5	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Ascend Laboratories, LLC	07e0ae51-cc71-427f-83cb-311b7fcc5993	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Camber Pharmaceuticals, Inc.	c9b51794-3cfa-4a34-b5bb-d523b5798c17	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	6783eaa8-e236-4957-aaa9-b42bf8e709a7	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Micro Labs Limited	721dde68-db83-4dad-8649-8046cb455372	2026-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Bryant Ranch Prepack	75fcff4a-1b35-4d92-8477-ff5ce7427f5f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
SYMPAZAN	CLOBAZAM	Aquestive Therapeutics	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Lupin Pharmaceuticals, Inc.	d9e03a2a-3fea-4c98-ab71-415e6ebda3e0	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	American Health Packaging	8fce3252-95f8-4428-9922-5ba308e20177	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Precision Dose, Inc.	6332e71c-3b37-422c-838c-8a2489ac6009	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Ascend Laboratories, LLC	a77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Golden State Medical Supply, Inc.	2166ea46-28ff-f492-e063-6394a90a4a45	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Camber Pharmaceuticals, Inc.	cf31b8d1-0d19-4529-99b6-1f7366064a3c	2024-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	NorthStar RxLLC	6f94e10e-ee4e-44e1-9c84-16c5d8c9b594	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Upsher-Smith Laboratories, LLC	6da2c381-057b-456a-b57b-464f8b383371	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
CLOBAZAM	CLOBAZAM	Novadoz Pharmaceuticals LLC	cf5bb37f-5386-47d3-8cec-d48253d359f6	2024-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Amneal Pharmaceuticals NY LLC	a526ad73-d3c1-40b7-8e71-426b01cdea27	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Chartwell RX, LLC	17c3b9db-9e25-4a17-ac45-bcd17ea0360c	2024-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	Aurobindo Pharma Limited	1b5749a1-1c6d-4243-a833-4bfd84f9d5a9	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM
Clobazam	CLOBAZAM	NorthStar RxLLC	574a3f91-d73e-46bc-b4a1-2388439521fb	2023-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBAZAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-314	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-315	Onfi	clobazam	Lundbeck Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77822	SUPPL	2024-03-13
77805	SUPPL	2024-03-13
77804	SUPPL	2024-03-13
73206	SUPPL	2023-01-17
73205	SUPPL	2023-01-17
73182	SUPPL	2023-01-17
66151	SUPPL	2021-02-09
66150	SUPPL	2021-02-09
66124	SUPPL	2021-02-09
54657	SUPPL	2018-06-21
54654	SUPPL	2018-06-21
54631	SUPPL	2018-06-20
46472	SUPPL	2016-12-22
46285	SUPPL	2016-12-20
19050	SUPPL	2015-05-12
32166	SUPPL	2014-12-11
32165	SUPPL	2013-11-26
40108	SUPPL	2013-11-22
40107	SUPPL	2013-03-05
22868	ORIG	2011-11-22
9948	ORIG	2011-10-25
19049	ORIG	2011-10-24