Application 207798

Type: ANDA
Sponsor: UMEDICA LABS PVT LTD

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207798-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET / ORAL	BX		2020-04-15
A207798-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	BX		2020-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207798-001	BX
A207798-002	BX

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 2 · 74 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	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A207798-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207798-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207798-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207798-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207798-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207798-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207798-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207798-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207798-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207798-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207798-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207798-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207798-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207798-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207798-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-002	AB	1	`87673890dc5c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 70518-2841
Carbamazepine	CARBAMAZEPINE	Coupler LLC	544e3b55-c8a3-a480-e063-6394a90abbb5	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	62d38b93-7dd0-48e7-bd59-a434d52520f6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 71335-1730
Carbamazepine	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 68788-7825
Carbamazepine	CARBAMAZEPINE	NIVAGEN PHARMACEUTICALS, INC.	e68998cb-5f91-4d7e-85a6-555efb8b0384	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 75834-220 ndc (product): 75834-221
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	047bc284-060a-4db9-bf37-75d10f95a0a6	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 50090-5740
CARBAMAZEPINE	CARBAMAZEPINE	direct rx	b56dd9c8-1bca-21e3-e053-2995a90a3e6e	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 72189-157

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5740	Carbamazepine	Carbamazepine	A-S Medication Solutions	ANDA	Current
50090-5740	Carbamazepine	Carbamazepine	A-S Medication Solutions	ANDA	Current
68788-7825	Carbamazepine	Carbamazepine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7825	Carbamazepine	Carbamazepine	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2841	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2841	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2841	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2841	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
71335-1730	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
71335-1730	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
72189-157	CARBAMAZEPINE	CARBAMAZEPINE	direct rx	ANDA	Current
75834-220	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-220	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-220	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-220	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-220	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-221	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-221	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-221	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-221	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-221	Carbamazepine	Carbamazepine	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current