Application 021710

Type: NDA
Sponsor: VALIDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EQUETRO	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	EQUETRO	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	No
003	EQUETRO	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	Yes	Yes

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

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	Approval date
N021710-001	EQUETRO	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10
N021710-002	EQUETRO	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10
N021710-003	EQUETRO	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-001	6977253	2024-05-19	U-693	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-002	6977253	2024-05-19	U-693	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-003	6977253	2024-05-19	U-693	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-001	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-002	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-003	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-001	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-002	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-003	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-001	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-002	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-003	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021710-001	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-002	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-003	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-001	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-002	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-003	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-001	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-002	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-003	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-001	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-002	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-003	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021710-001	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021710-002	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021710-003	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-001	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-002	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-003	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021710-001	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021710-002	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021710-003	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021710-001	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021710-002	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021710-003	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021710-001	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021710-002	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021710-003	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021710-001	6977253	2024-05-19	U-693	`bb7c543d1eb4…`

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
EQUETRO	CARBAMAZEPINE	Validus Pharmaceuticals LLC	be478f3c-40f6-47cc-8ab9-f420a9372b1c	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021710 application number: NDA021710 ndc (product): 30698-419 ndc (product): 30698-423 ndc (product): 30698-421

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-419	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-419	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-419	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-419	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-421	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-421	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-421	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-421	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-423	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-423	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-423	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current
30698-423	EQUETRO	Carbamazepine	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72390	SUPPL	2022-10-17
72389	SUPPL	2022-10-17
72356	SUPPL	2022-10-17
56344	SUPPL	2018-11-08
45421	SUPPL	2016-09-29
45420	SUPPL	2016-09-29
45372	SUPPL	2016-09-26
45371	SUPPL	2016-09-26
16236	SUPPL	2012-11-15
6026	SUPPL	2012-11-14
28430	SUPPL	2012-01-31
16235	SUPPL	2010-10-28
28427	SUPPL	2010-10-27
37496	SUPPL	2009-05-13
6025	SUPPL	2009-05-04
28426	SUPPL	2008-01-09
28425	SUPPL	2006-12-28
37495	SUPPL	2006-12-14
21783	ORIG	2006-07-05
37494	ORIG	2004-12-10
28424	ORIG	2004-12-10