Application 216594

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, 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
A216594-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18
A216594-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18
A216594-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216594-001	AB
A216594-002	AB
A216594-003	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 · 81 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	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216594-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-08-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 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	A216594-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216594-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216594-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216594-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216594-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216594-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216594-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216594-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216594-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216594-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216594-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216594-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216594-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216594-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216594-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216594-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216594-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216594-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216594-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216594-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	cd8b51f4-8427-4b18-9d2c-10771d2a6580	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d3cd36c4-b25e-4716-be1d-0b2c83ea6a03	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	48080efd-1781-4585-83f8-c43957ac63b3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	20cd4276-afb1-43e5-abb3-e2af7f8a71dd	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	3207764f-0663-477e-ad1f-f5fb43b6bbf3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	Northstar Rx LLC	b563e4a1-d7dd-4901-ad45-614f85687589	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594
Carbamazepine	CARBAMAZEPINE	Jubilant Cadista Pharmaceuticals Inc.	7c1dd8ce-c490-40b4-b17a-da331df24cba	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216594 application number: ANDA216594 ndc (product): 59746-790 ndc (product): 59746-791 ndc (product): 59746-789

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-789	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-789	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-790	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-790	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-791	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-791	Carbamazepine	Carbamazepine	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current