Application 075687

Type: ANDA
Sponsor: TARO PHARM INDS

Application Products#

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

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
A075687-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24
A075687-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075687-001	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`782e0a99824c…`

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	A075687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075687-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075687-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 70518-2426
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	d0121be3-b904-41d3-a81a-292aa4176491	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 70518-1433
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	536811ab-308b-4866-9185-9e4149483512	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 60429-934
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 51672-4041
Carbamazepine	CARBAMAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	963db7cf-e9f5-496c-816e-626e89bc839e	2022-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 0615-8125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0947	Carbamazepine	Carbamazepine	Pharamaceutical Associates, Inc.	ANDA	Current
0121-1894	Carbamazepine	Carbamazepine	Pharamaceutical Associates, Inc.	ANDA	Current
0615-8125	Carbamazepine	Carbamazepine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8125	Carbamazepine	Carbamazepine	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
51672-4041	Carbamazepine	Carbamazepine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
60429-934	Carbamazepine	carbamazepine	Golden State Medical Supply, Inc.	ANDA	Current
60429-934	Carbamazepine	Carbamazepine	Golden State Medical Supply, Inc.	ANDA	Current
68788-9812	Carbamazepine	Carbamazepine	Preferred Pharmaceuticals, Inc	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-1433	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2426	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2426	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2426	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current
70518-2426	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24153	ORIG	2008-02-01
8765	ORIG	2000-10-24