Application 022500

Type: NDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE	CLONIDINE	TABLET, EXTENDED RELEASE;ORAL	EQ 0.17MG BASE	No	No
002	CLONIDINE	CLONIDINE	TABLET, EXTENDED RELEASE;ORAL	EQ 0.26MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022500-001	NEXICLON XR	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL			2009-12-03
N022500-002	NEXICLON XR	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL			2009-12-03

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022500-001	8337890	2027-04-17	Drug product	2020-07-01
N022500-001	8623409	2031-09-08	Drug product	2020-07-01
N022500-002	8337890	2027-04-17	Drug product	2020-07-01
N022500-002	8623409	2031-09-08	Drug product	2020-07-01

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexiclon XR	CLONIDINE	Rosemont Pharmaceuticals LLC	dad35a6f-d57e-f302-e053-2995a90a9efb	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500 ndc (product): 71511-503
Clonidine	CLONIDINE	TruPharma, LLC	2311836b-de63-4e8c-a021-600c40110024	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500
Clonidine	CLONIDINE	PALMETTO PHARMACEUTICALS INC.	e93324f1-ad83-7bbe-e053-2995a90a8c9e	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500 ndc (product): 68134-603

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68134-603	Clonidine	Clonidine	PALMETTO PHARMACEUTICALS INC.	NDA AUTHORIZED GENERIC	Current
71511-503	Nexiclon XR	Clonidine	Athena Bioscience, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
38767	SUPPL	2010-09-29
29785	SUPPL	2010-09-29
44761	ORIG	2010-05-12
42539	ORIG	2010-05-12
7463	ORIG	2009-12-11
17647	ORIG	2009-12-10