Application 077802

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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 42.

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
A077802-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09
A077802-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09
A077802-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077802-001	AB
A077802-002	AB
A077802-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077802-001	AB	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 70518-3237
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a90cd1f1-5258-4b0e-92fd-c4cebe47772b	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 70518-3197
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	51008af2-39ac-546c-e063-6294a90a758f	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	50873ef7-3deb-7386-e063-6394a90a9c19	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Glenmark Pharmaceuticals Inc., USA	1c713b59-a628-42e6-b166-ae71c3913284	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 68462-137 ndc (product): 68462-138 ndc (product): 68462-139
Oxcarbazepine	OXCARBAZEPINE	Direct_rx	21b0cc84-b64a-75de-e063-6294a90a9dd0	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 71205-411

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-862	Oxcarbazepine	Oxcarbazepine	Rebel Distributors Corp	ANDA	Current
21695-863	Oxcarbazepine	Oxcarbazepine	Rebel Distributors Corp	ANDA	Current
21695-864	Oxcarbazepine	Oxcarbazepine	Rebel Distributors Corp	ANDA	Current
50090-3961	Oxcarbazepine	Oxcarbazepine	A-S Medication Solutions	ANDA	Current
55700-569	Oxcarbazepine	Oxcarbazepine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-569	TRILEPTAL	OXCARBAZEPINE	DIRECT RX	ANDA	Current
64725-0137	Oxcarbazepine	Oxcarbazepine	TYA Pharmaceuticals	ANDA	Current
68462-137	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-137	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-137	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-137	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-138	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-138	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-138	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-138	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-139	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-139	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-139	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-139	Oxcarbazepine	Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-3127	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current
70518-3127	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current
70518-3197	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current
70518-3197	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current
70518-3237	Oxcarbazepine	Oxcarbazepine	REMEDYREPACK INC.	ANDA	Current
71205-411	Oxcarbazepine	Oxcarbazepine	Proficient Rx LP	ANDA	Current
71205-411	Oxcarbazepine	Oxcarbazepine	Proficient Rx LP	ANDA	Current
71335-0144	Oxcarbazepine	Oxcarbazepine	Bryant Ranch Prepack	ANDA	Current
71335-0410	Oxcarbazepine	Oxcarbazepine	Bryant Ranch Prepack	ANDA	Current
71335-0978	Oxcarbazepine	Oxcarbazepine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24168	ORIG	2007-10-23
39542	ORIG	2007-10-10
9086	ORIG	2007-10-10