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 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075687-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075687-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075687-001	AB	1	`caaa826d4ba7…`
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…`

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Jubilant Cadista Pharmaceuticals Inc.	7c1dd8ce-c490-40b4-b17a-da331df24cba	2026-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Apotex Corp.	e91f9de3-3fdd-0a6b-71ce-53a2cc142816	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Northstar Rx LLC	c91a5a1b-5481-445b-86e8-f10109ac3937	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Apotex Corp.	bf0d012f-da14-8ce3-d74f-56172cddebc5	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Ascend Laboratories, LLC	f0a254c5-bd33-4b14-b9f0-830b3438f5c6	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbatrol	CARBAMAZEPINE	Takeda Pharmaceuticals America, Inc.	bc03e499-5bac-4293-bff4-6864153a624d	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Unichem Pharmaceuticals (USA), Inc.	50ba2042-fc67-4266-a773-a30f07649a5a	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Alembic Pharmaceuticals Inc.	87d343a8-84d5-4cdd-b0a0-629311b51f11	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Zydus Lifesciences Limited	d10e5f83-56db-4bc9-8c51-150a2e3e20ea	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carbamazepine generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Zydus Pharmaceuticals (USA) Inc.	c5e4a25a-0137-4327-96f5-15735891ad5c	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	7c4860c1-daba-4e0f-97fd-d30cbc8603a2	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	American Health Packaging	7108d630-89bc-4815-b6fb-a1f4676c496e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Bionpharma Inc.,	138d9ed1-2f8e-d19d-e063-6394a90a695d	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Coupler LLC	5461e739-0f18-b012-e063-6394a90a6b14	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler LLC	544e3b55-c8a3-a480-e063-6394a90abbb5	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Ajanta Pharma USA Inc.	2e3c4854-89a1-4e3f-88d4-e164829585fb	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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