Application 210942

Type: NDA
Sponsor: AVION PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLOPERBA	COLCHICINE	SOLUTION;ORAL	0.6MG/5ML	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210942-001	GLOPERBA	COLCHICINE	0.6MG/5ML	SOLUTION / ORAL		RLD, RS	2019-01-30

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28
N210942-001	10383821	2036-11-22		Drug product	2019-08-28
N210942-001	12274751	2036-11-22	U-2814		2025-04-25
N210942-001	12514819	2036-11-22	U-2814		2026-02-03
N210942-001	9907751	2036-11-22		Drug product	2019-02-26
N210942-001	10226423	2037-12-20		Drug product	2019-03-27

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210942-001	12514819	2036-11-22	U-2814		2026-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	12514819	2036-11-22	U-2814		2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`5bbf6a4d5a75…`

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
Gloperba	COLCHICINE	Scilex Pharmaceuticals Inc.	467cd83f-d695-4040-9434-10e80b4271da	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210942 application number: NDA210942

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72690-010	Gloperba	colchicine	ROMEG Therapeutics, LLC	NDA	Current
75854-801	Gloperba	colchicine	Avion Pharmaceuticals, LLC	NDA	Current
75854-801	Gloperba	colchicine	Avion Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79512	SUPPL	2024-09-02
79013	SUPPL	2024-09-02
79504	SUPPL	2024-08-29
79503	SUPPL	2024-08-29
67712	SUPPL	2021-06-04
67711	SUPPL	2021-06-04
67699	SUPPL	2021-06-04
58132	ORIG	2019-03-28
57550	ORIG	2019-02-13
57392	ORIG	2019-01-31
57391	ORIG	2019-01-31