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N017407-001	CATAPRES	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017407-002	CATAPRES	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017407-003	CATAPRES	CLONIDINE HYDROCHLORIDE	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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N017407-001	CATAPRES	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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N017407-002	CATAPRES	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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N017407-003	CATAPRES	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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 2 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	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	666e757e-9b43-2e40-e053-2991aa0a59a2	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	50c8a725-a449-256b-e063-6294a90a3e44	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	32e740a9-51e1-4add-8f99-523fb9cb8b2e	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	b359baee-6faf-4f7d-be86-ba7a1b1de770	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0906c25f-e5b8-4a08-9b10-d1f06419e275	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	c8e151d6-50c6-47a1-80b0-bd8e07acddd2	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e413efdf-980b-4b33-80f1-5be899a10f01	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	55ab721b-7b4c-42d5-99e3-745008fe139c	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	56a80e79-9cfe-4361-a90a-9245632efa05	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	770b56aa-fcf3-4327-98d1-d87e5a037234	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	21bfa28f-20df-43fd-bb80-b720d3b40696	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7484e8fa-13a7-70e9-e053-2a91aa0a24b7	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	a32f4b18-1090-4d79-a56b-39c0cf366bbc	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1ab3b82f-db7f-22bf-e063-6294a90ae93f	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	ab2ffb6e-7070-063b-e053-2a95a90aff22	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	66dc3cf0-d6bd-436c-9a7f-7477575b3260	2026-01-01	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