Application 209718

Type: ANDA
Sponsor: AMNEAL PHARMS CO

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
A209718-001	CLOBAZAM	CLOBAZAM	10MG	TABLET / ORAL	AB		2018-10-22
A209718-002	CLOBAZAM	CLOBAZAM	20MG	TABLET / ORAL	AB		2018-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209718-001	AB
A209718-002	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 3 · 82 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	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209718-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209718-002	CLOBAZAM	20MG	TABLET / ORAL	AB	2018-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A209718-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209718-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209718-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209718-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209718-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209718-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209718-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209718-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209718-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209718-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209718-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209718-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209718-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209718-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209718-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209718-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209718-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209718-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209718-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209718-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209718-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209718-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209718-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209718-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209718-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209718-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209718-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209718-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209718-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209718-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209718-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209718-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209718-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209718-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209718-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209718-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209718-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209718-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209718-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209718-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	6783eaa8-e236-4957-aaa9-b42bf8e709a7	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209718 application number: ANDA209718 ndc (product): 69238-1306 ndc (product): 69238-1305
Clobazam	CLOBAZAM	American Health Packaging	8fce3252-95f8-4428-9922-5ba308e20177	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209718 application number: ANDA209718 ndc (product): 60687-423

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-423	Clobazam	Clobazam	American Health Packaging	ANDA	Current
60687-423	Clobazam	Clobazam	American Health Packaging	ANDA	Current
60687-423	Clobazam	Clobazam	American Health Packaging	ANDA	Current
60687-423	Clobazam	Clobazam	American Health Packaging	ANDA	Current
60687-423	Clobazam	Clobazam	American Health Packaging	ANDA	Current
69238-1305	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1305	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1305	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1305	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1305	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1306	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1306	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1306	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1306	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1306	CLOBAZAM	CLOBAZAM	Amneal Pharmaceuticals LLC	ANDA	Current