Application 074649

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074649-001	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		1996-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074649-001	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 2 · 41 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	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A074649-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074649-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074649-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074649-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074649-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074649-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074649-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074649-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074649-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074649-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074649-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074649-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074649-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074649-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074649-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074649-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074649-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074649-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074649-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074649-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074649-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074649-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074649-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074649-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074649-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074649-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074649-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074649-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074649-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074649-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074649-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074649-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074649-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074649-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074649-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074649-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074649-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074649-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074649-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074649-001	AB	1	`cb3db0bc1861…`

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.	40bf2923-24b1-4af1-8d20-03cf06b455a5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 70518-2242
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 50090-0384
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	8a1ce79d-18ea-f30b-e053-2995a90ad1fb	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 51407-215
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 51672-4005
Carbamazepine	CARBAMAZEPINE	PD-Rx Pharmaceuticals, Inc.	ce5aec7a-e161-46bf-8fc0-afb41689e59a	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 43063-328
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	2d2c5317-4072-477b-a4e2-f6765fc71657	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 71335-0461
Carbamazepine	CARBAMAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	10c9795e-358c-4f6a-b7bc-cccc179617c0	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	697f3e5a-c84b-44a6-b9f3-15e7d9bb6395	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-724	Carbamazepine	Carbamazepine	Rebel Distributors Corp	ANDA	Current
33261-676	Carbamazepine	Carbamazepine	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-328	Carbamazepine	Carbamazepine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-328	Carbamazepine	Carbamazepine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-328	Carbamazepine	Carbamazepine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-328	Carbamazepine	Carbamazepine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0384	Carbamazepine	Carbamazepine	A-S Medication Solutions	ANDA	Current
50090-4443	Carbamazepine	Carbamazepine	A-S Medication Solutions	ANDA	Current
51407-215	Carbamazepine	Carbamazepine	Golden State Medical Supply Inc.	ANDA	Current
51407-215	Carbamazepine	Carbamazepine	Golden State Medical Supply Inc.	ANDA	Current
51407-215	Carbamazepine	Carbamazepine	Golden State Medical Supply Inc.	ANDA	Current
51672-4005	Carbamazepine	Carbamazepine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53808-0913	Carbamazepine	CARBAMAZEPINE	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0916	Carbamazepine	CARBAMAZEPINE	State of Florida DOH Central Pharmacy	ANDA	Current
64725-4005	Carbamazepine	Carbamazepine	TYA Pharmaceuticals	ANDA	Current
67046-009	Carbamazepine	Carbamazepine	Contract Pharmacy Services-PA	ANDA	Current
68071-2701	Carbamazepine	Carbamazepine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3282	Carbamazepine	Carbamazepine	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-1436	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1436	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1436	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1436	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1436	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2242	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
71335-0461	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
71335-0461	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
71335-0461	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
71610-336	Carbamazepine	Carbamazepine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24151	ORIG	2008-02-01