Application 074979

Type: ANDA
Sponsor: SANDOZ

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
A074979-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29
A074979-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29
A074979-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074979-001	AB
A074979-002	AB
A074979-003	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	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1997-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1997-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074979-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1997-08-29	`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	A074979-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074979-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074979-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074979-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074979-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074979-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074979-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074979-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074979-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074979-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074979-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074979-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074979-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074979-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074979-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074979-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074979-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074979-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074979-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074979-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074979-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074979-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074979-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074979-001	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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Chartwell RX, LLC	7b543f77-4388-4227-942f-7933f200b3a5	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5f3a2f64-57ed-475c-9d8c-b2094bf1d79e	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5ae98718-9da5-4edc-8efb-67b212577548	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	cc14bb7b-d0c8-4f41-bcd9-a0c860b45a43	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	645fb912-479c-46de-b99c-4ea341bfd9ba	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	6be64dc3-3748-477c-8800-2c2175309c73	2023-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	6960e994-e9ea-4a4a-b674-7e6124d8b381	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Teva Pharmaceuticals USA, Inc.	8069b1a0-7c06-4252-b44e-e2eef065d9b8	2023-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aurobindo Pharma Limited	b1582eb7-af35-45d5-a52e-0e380d08527d	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	43ee20ce-0015-413c-b230-822e390b02f7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLONAZEPAM generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	4dcb6785-e16b-4692-89b3-f905979ca5ae	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	56175c25-3fde-43ea-89bf-22dcf3278b6b	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	63286201-4b79-45b8-8f48-7e21dadc1408	2021-02-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	c68420a9-b646-4a4f-99f7-43d652312eb0	2018-02-14	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 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0063	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0185-0063	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0185-0064	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0185-0064	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0185-0065	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0185-0065	Clonazepam	Clonazepam	Eon Labs, Inc.	ANDA	Current
0781-5567	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0781-5567	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0781-5569	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0781-5569	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0781-8018	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0781-8018	Clonazepam	Clonazepam	Sandoz Inc	ANDA	Current
0904-6101	Clonazepam	Clonazepam	Major Pharmaceuticals	ANDA	Current
0904-6102	Clonazepam	Clonazepam	Major Pharmaceuticals	ANDA	Current
0904-6103	Clonazepam	Clonazepam	Major Pharmaceuticals	ANDA	Current
16714-469	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-469	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-470	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-470	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-471	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-471	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-750	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-750	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-751	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-751	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-752	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
16714-752	Clonazepam	Clonazepam	Northstar RxLLC	ANDA	Current
50090-1565	Clonazepam	Clonazepam	A-S Medication Solutions	ANDA	Current
50090-2878	Clonazepam	Clonazepam	A-S Medication Solutions	ANDA	Current
50090-2878	Clonazepam	Clonazepam	A-S Medication Solutions	ANDA	Current
50090-3467	Clonazepam	Clonazepam	A-S Medication Solutions	ANDA	Current
53217-189	Clonazepam	Clonazepam	Aidarex Pharmaceuticals LLC	ANDA	Current
53217-247	Clonazepam	Clonazepam	Aidarex Pharmaceuticals LLC	ANDA	Current
53217-326	Clonazepam	Clonazepam	Aidarex Pharmaceuticals LLC	ANDA	Current
70518-0154	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-0259	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-0259	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1069	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1069	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1199	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1199	Clonazepam	Clonazepam	REMEDYREPACK INC.	ANDA	Current
71335-0001	Clonazepam	Clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0001	Clonazepam	Clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-1060	Clonazepam	Clonazepam	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22398	ORIG	2011-03-10