Application 209440

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBAZAM	CLOBAZAM	TABLET;ORAL	10MG	No	No
002	CLOBAZAM	CLOBAZAM	TABLET;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209440-001	CLOBAZAM	CLOBAZAM	10MG	TABLET / ORAL			2018-10-22
A209440-002	CLOBAZAM	CLOBAZAM	20MG	TABLET / ORAL			2018-10-22

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A209440-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209440-002	AB	1	`ea99ee380514…`

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 2 · 22 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 brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Ascend Laboratories, LLC	07e0ae51-cc71-427f-83cb-311b7fcc5993	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Camber Pharmaceuticals, Inc.	c9b51794-3cfa-4a34-b5bb-d523b5798c17	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	6783eaa8-e236-4957-aaa9-b42bf8e709a7	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOBAZAM generic name: CLOBAZAM
Clobazam	CLOBAZAM	Micro Labs Limited	721dde68-db83-4dad-8649-8046cb455372	2026-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Bryant Ranch Prepack	75fcff4a-1b35-4d92-8477-ff5ce7427f5f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam 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 brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	American Health Packaging	8fce3252-95f8-4428-9922-5ba308e20177	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Precision Dose, Inc.	6332e71c-3b37-422c-838c-8a2489ac6009	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Ascend Laboratories, LLC	a77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam 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 brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Bionpharma Inc.	4b92ac57-25aa-4c00-b062-dee3944b271b	2024-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Camber Pharmaceuticals, Inc.	cf31b8d1-0d19-4529-99b6-1f7366064a3c	2024-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	NorthStar RxLLC	6f94e10e-ee4e-44e1-9c84-16c5d8c9b594	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Upsher-Smith Laboratories, LLC	6da2c381-057b-456a-b57b-464f8b383371	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
CLOBAZAM	CLOBAZAM	Novadoz Pharmaceuticals LLC	cf5bb37f-5386-47d3-8cec-d48253d359f6	2024-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOBAZAM generic name: CLOBAZAM
Clobazam	CLOBAZAM	Amneal Pharmaceuticals NY LLC	a526ad73-d3c1-40b7-8e71-426b01cdea27	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Chartwell RX, LLC	17c3b9db-9e25-4a17-ac45-bcd17ea0360c	2024-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM
Clobazam	CLOBAZAM	Aurobindo Pharma Limited	1b5749a1-1c6d-4243-a833-4bfd84f9d5a9	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobazam generic name: CLOBAZAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4202	Clobazam	clobazam	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4203	Clobazam	clobazam	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current