Application 077747

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;ORAL	150MG	No	No
002	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;ORAL	300MG	No	No
003	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;ORAL	600MG	No	No

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	TE codes	Approval date
A077747-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09
A077747-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09
A077747-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077747-001	AB
A077747-002	AB
A077747-003	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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-04-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-04-09	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077747-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077747-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077747-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077747-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077747-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077747-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077747-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077747-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077747-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077747-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077747-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077747-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077747-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077747-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077747-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077747-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077747-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077747-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077747-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077747-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077747-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077747-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077747-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077747-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077747-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077747-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077747-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077747-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077747-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077747-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077747-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077747-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077747-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077747-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077747-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077747-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077747-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077747-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077747-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077747-001	AB	1	`79d66fd596c7…`

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
Oxcarbazepine	OXCARBAZEPINE	Advagen Pharma Limited	b0bc10f0-7d1b-4adc-bc59-c48dab58ee5a	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077747 application number: ANDA077747

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44536	ORIG	2011-02-15
22612	ORIG	2011-02-15
23885	ORIG	2008-04-25