Application 213311

Type: ANDA
Sponsor: CSPC OUYI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAMAZEPINE	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	CARBAMAZEPINE	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No
003	CARBAMAZEPINE	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A213311-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13
A213311-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13
A213311-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213311-001	AB
A213311-002	AB
A213311-003	AB

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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213311-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213311-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213311-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213311-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213311-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213311-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213311-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213311-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213311-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213311-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213311-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213311-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213311-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213311-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213311-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213311-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213311-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213311-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213311-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213311-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213311-001	AB	1	`8072bd15b7f6…`

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
Carbamazepine	CARBAMAZEPINE	Upsher-Smith Laboratories, LLC	282c954f-e34a-4bd5-b5eb-771e3c56936f	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213311 application number: ANDA213311 ndc (product): 0832-6022 ndc (product): 0832-6023 ndc (product): 0832-6024

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
0832-6022	Carbamazepine	Carbamazepine	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-6023	Carbamazepin	Carbamazepine	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-6024	Carbamazepine	Carbamazepine	Upsher-Smith Laboratories, LLC	ANDA	Current