Application 017533

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLONOPIN	CLONAZEPAM	TABLET;ORAL	0.5MG	Yes	No
002	KLONOPIN	CLONAZEPAM	TABLET;ORAL	1MG	Yes	Yes
003	KLONOPIN	CLONAZEPAM	TABLET;ORAL	2MG	Yes	No
005	KLONOPIN	CLONAZEPAM	TABLET;ORAL	0.125MG	No	No
006	KLONOPIN	CLONAZEPAM	TABLET;ORAL	0.25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017533-001	KLONOPIN	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017533-002	KLONOPIN	CLONAZEPAM	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N017533-003	KLONOPIN	CLONAZEPAM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017533-005	KLONOPIN	CLONAZEPAM	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09
N017533-006	KLONOPIN	CLONAZEPAM	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017533-001	AB
N017533-002	AB
N017533-003	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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-005	KLONOPIN	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-006	KLONOPIN	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017533-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017533-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017533-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017533-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017533-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017533-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017533-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Klonopin	CLONAZEPAM	H2-Pharma, LLC	cfa0d79a-843c-4b88-95a1-e9511d649ca1	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017533 application number: NDA017533 ndc (product): 61269-620 ndc (product): 61269-605 ndc (product): 61269-610

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0058	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0068	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
0004-0098	Klonopin	Clonazepam	Genentech, Inc.	NDA	Current
61269-605	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
61269-605	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
61269-610	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
61269-610	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
61269-620	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
61269-620	Klonopin	Clonazepam	H2-Pharma, LLC	NDA	Current
65084-308	Klonopin	Clonazepam	Mckesson Rxpak Inc	NDA	Current
65084-309	Klonopin	Clonazepam	Mckesson Rxpak Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73201	SUPPL	2023-01-17
73200	SUPPL	2023-01-17
73167	SUPPL	2023-01-17
66147	SUPPL	2021-02-09
66146	SUPPL	2021-02-09
66126	SUPPL	2021-02-09
50222	SUPPL	2017-10-30
50188	SUPPL	2017-10-26
50187	SUPPL	2017-10-26
46460	SUPPL	2016-12-22
46281	SUPPL	2016-12-20
33297	SUPPL	2016-03-29
13836	SUPPL	2016-03-29
628	SUPPL	2013-11-06
11020	SUPPL	2013-11-01
33295	SUPPL	2012-06-04
626	SUPPL	2012-06-04
13835	SUPPL	2011-12-14
627	SUPPL	2010-09-21
33296	SUPPL	2010-09-07
11019	SUPPL	2009-05-12
625	SUPPL	2009-05-01
40747	SUPPL	2007-04-09
20077	SUPPL	2007-04-09
624	SUPPL	2002-01-29
623	SUPPL	2001-01-22