Application 074869

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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
A074869-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31
A074869-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31
A074869-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074869-001	AB
A074869-002	AB
A074869-003	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	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074869-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-10-31	`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	A074869-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074869-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074869-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074869-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074869-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074869-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074869-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074869-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074869-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074869-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074869-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074869-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074869-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074869-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074869-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074869-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074869-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074869-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074869-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074869-001	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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	64bb2cdf-f57d-4a41-a5bf-ee77b6e64d06	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	19475112-60da-4d53-b330-70afe28ebaf3	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	c4b87c17-efcd-4b66-96e7-159a04c808b5	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	8bb69bbe-07e1-4123-9b70-fde78d1d0a34	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	874b0395-fecb-446a-966f-6ecbb23f1ff6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Advagen Pharma Ltd	30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Coupler LLC	54d6e348-4c51-221e-e063-6294a90a9b7d	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	533a12a8-64fb-494f-a2a4-da1515ef1908	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Unit Dose Solutions, Inc.	54789918-cc0c-7090-e063-6394a90aeba7	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	1fb0807c-dccd-47a5-ada4-91418c4f47f5	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	f613573a-3e8b-4abf-af69-0268f3d6f481	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Major Pharmaceuticals	34366dd2-432c-4fa9-8fab-832cca781b84	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
clonazepam	CLONAZEPAM	Advagen Pharma Ltd	19fc756c-72fe-4504-beaa-4fa2235af18c	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Coupler LLC	511216c7-6878-f90a-e063-6394a90aaac8	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Cardinal Health 107, LLC	5ad315f2-fa09-4956-b931-f9966fb73e4e	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	2fe0d214-9c4d-4a0c-9024-c2076c092c1a	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	f803fefc-69ff-4963-950b-48c13998bc2c	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM

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 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71610-023	Clonazepam	Clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current