Application 022331

Type: NDA
Sponsor: CONCORDIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JENLOGA	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	JENLOGA	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	KAPVAY	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.1MG	Yes	Yes
004	KAPVAY	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022331-001	JENLOGA	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30
N022331-002	JENLOGA	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25
N022331-003	KAPVAY	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28
N022331-004	KAPVAY	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022331-003	KAPVAY	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022331-003	KAPVAY	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-003	KAPVAY	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022331-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022331-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022331-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022331-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022331-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022331-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022331-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022331-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022331-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022331-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022331-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022331-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022331-003	AB1	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N022331-003	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022331-003	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022331-003	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022331-003	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022331-003	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022331-003	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022331-003	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022331-003	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022331-003	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022331-003	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022331-003	AB1	1	`cb3db0bc1861…`

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61848	SUPPL	2020-02-07
61838	SUPPL	2020-02-07
48433	SUPPL	2017-05-17
45195	SUPPL	2016-08-16
45130	SUPPL	2016-08-16
38587	SUPPL	2015-06-10
29606	SUPPL	2015-06-10
17250	SUPPL	2014-12-16
29605	SUPPL	2014-11-21
17249	SUPPL	2013-02-14
7246	SUPPL	2013-02-14
38586	SUPPL	2010-10-07
17248	SUPPL	2010-10-07
17247	SUPPL	2010-10-07
29604	SUPPL	2010-10-04
29603	SUPPL	2010-10-04
21995	ORIG	2009-11-10
38585	ORIG	2009-10-07
7245	ORIG	2009-10-07
66954	ORIG	1900-01-01
66953	ORIG	1900-01-01
66952	ORIG	1900-01-01
53219	ORIG	1900-01-01
53218	ORIG	1900-01-01
53216	ORIG	1900-01-01