Application 077795

Type: ANDA
Sponsor: HIKMA

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 43.

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	Approval date
A077795-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09
A077795-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09
A077795-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077795-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077795-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2007-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077795-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2007-10-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077795-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077795-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077795-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077795-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077795-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077795-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077795-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077795-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077795-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077795-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077795-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077795-003	AB	1	`ea99ee380514…`

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 3 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXCARBAZEPINE	OXCARBAZEPINE	Golden State Medical Supply, Inc.	b9db5c45-8b51-449b-b4af-1a235c08f189	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Glenmark Pharmaceuticals Inc., USA	1c713b59-a628-42e6-b166-ae71c3913284	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Ajanta Pharma USA Inc.	d947e9b1-2a15-4048-bb4e-fe56b6851848	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Bionpharma Inc.	ec033897-21b4-4d08-83de-042783e89251	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	a1b6a698-f7d9-4adb-9e38-b63e7a85e2b3	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	1176d5f5-3447-4925-aed8-1a1cb4b5989d	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Amneal Pharmaceuticals LLC	2515391e-3a88-4226-92e5-f641c8409fe5	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Coupler LLC	3f15c889-4386-850b-e063-6294a90a8dbf	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Preferred Pharmaceuticals Inc.	e156339c-f79e-4a20-b9da-f50bea948213	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
oxcarbazepine	OXCARBAZEPINE	Macleods Pharmaceuticals Limited	962098cc-2d84-4723-a296-b110f1fd659e	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Ascend Laboratories, LLC	3f36f519-c30c-4929-afa0-9844dc531e3f	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Marlex Pharmaceuticals, Inc	d3684d55-0564-4849-bdf6-b91f22a3e28c	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Ingenus Pharmaceuticals, LLC	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	433d9d03-a36e-42c6-8e4d-f333ed60e45a	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	NorthStar RxLLC	1746d95f-c529-45ba-a520-0c135e8edda8	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	DirectRx	dbea45c2-e166-b557-e053-2995a90a7643	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Bryant Ranch Prepack	23137a89-cbd0-4a5f-8220-f26b7ba54330	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	AvPAK	fd8da0e9-d69b-7587-e053-6294a90a33c0	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	EPIC PHARMA, LLC	62ab716b-f05f-454d-95b3-1a382cdf7226	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Novadoz Pharmaceuticals LLC	03bec567-a9c3-4d82-9679-fec5324d0df6	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0097	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0097	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals	ANDA	Current
0054-0097	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0097	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0097	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0098	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0098	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals	ANDA	Current
0054-0098	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0098	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0098	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0099	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0099	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals	ANDA	Current
0054-0099	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0099	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
0054-0099	Oxcarbazepine	Oxcarbazepine	West-Ward Pharmaceticals Corp.	ANDA	Current
50090-2573	Oxcarbazepine	Oxcarbazepine	A-S Medication Solutions	ANDA	Current
55154-4959	Oxcarbazepine	Oxcarbazepine	Cardinal Health	ANDA	Current
70518-0111	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24166	ORIG	2007-10-23
39541	ORIG	2007-10-10
9084	ORIG	2007-10-10