Application 074569

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	0.5MG	No	No
002	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	1MG	No	No
003	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A074569-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10
A074569-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10
A074569-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074569-001	AB
A074569-002	AB
A074569-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074569-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074569-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074569-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-001	AB	1	`301d65b070ca…`

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
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	64bb2cdf-f57d-4a41-a5bf-ee77b6e64d06	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569 ndc (product): 70518-3144
Clonazepam	CLONAZEPAM	Coupler LLC	54d6e348-4c51-221e-e063-6294a90a9b7d	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	b1c53213-9f84-4389-b6dc-3dc26d9a6364	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569 ndc (product): 70518-2507
Clonazepam	CLONAZEPAM	A-S Medication Solutions	b3c9d04a-431f-4cec-a809-847dfb8de736	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Clinical Solutions Wholesale, LLC	429a15d1-1675-42cc-97f1-c49b03747416	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	73125f86-ce24-44c0-a2b1-a5d12a607a94	2023-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	6be64dc3-3748-477c-8800-2c2175309c73	2023-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Teva Pharmaceuticals USA, Inc.	8069b1a0-7c06-4252-b44e-e2eef065d9b8	2023-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Proficient Rx LP	56175c25-3fde-43ea-89bf-22dcf3278b6b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569

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 2 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2507	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-3144	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-3144	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-3144	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-3583	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
71610-061	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-075	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-075	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-075	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-084	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-084	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-084	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-085	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-085	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-085	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-366	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-367	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current