Application 017407

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CATAPRES	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	Yes	No
002	CATAPRES	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	Yes	No
003	CATAPRES	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	Yes	Yes

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	RLD / RS
N017407-001	CATAPRES	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017407-002	CATAPRES	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017407-003	CATAPRES	CLONIDINE HYDROCHLORIDE	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017407-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017407-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017407-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017407-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017407-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017407-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017407-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017407-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017407-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017407-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017407-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017407-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017407-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017407-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017407-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017407-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017407-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017407-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017407-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017407-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017407-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017407-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017407-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017407-003	AB	1	`ea99ee380514…`

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 6 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	88a8db46-0fc9-48cd-b7cc-ac9c9cdea100	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	33c68d5e-6a68-40fd-a326-bf36a7e01d5b	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	38680c1d-3929-40d5-bda9-4eea5693afca	2022-08-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	2a5b46ec-4c16-48a5-9e58-8d28a3f21274	2022-06-27	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	2022-06-08	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Duraclon	CLONIDINE HYDROCHLORIDE	Mylan Institutional LLC	8c126bb8-732a-4949-8754-2f50b5543638	2021-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Xiamen LP Pharmaceutical Co., Ltd.	7676af27-4d8f-49c4-a50f-6b0892e73c8f	2020-10-27	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	b60034a6-b8ba-4e54-9ef0-029965e67bc0	2020-10-24	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	00d1562d-b4eb-4d89-95de-0aacee7a82a5	2020-07-29	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	c812012c-4b1d-40a4-8d4e-aaae2bf1c852	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e9b22c56-a3fc-46df-b745-11c4ac309a91	2017-05-03	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0006	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0006	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0007	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0007	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0011	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0011	Catapres	clonidine hydrochloride	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10985	SUPPL	2012-06-06
13132	SUPPL	2012-06-05
10984	SUPPL	2010-04-19
13131	SUPPL	2010-04-09
33260	SUPPL	2010-01-08
577	SUPPL	2010-01-06
576	SUPPL	2010-01-06
10983	SUPPL	2009-11-13