Application 073524

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPITOL	CARBAMAZEPINE	TABLET, CHEWABLE;ORAL	100MG	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
A073524-001	EPITOL	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		1992-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073524-001	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	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073524-001	EPITOL	100MG	TABLET, CHEWABLE / ORAL	AB	1992-07-29	`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	A073524-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073524-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073524-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073524-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073524-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073524-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073524-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073524-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073524-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073524-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073524-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073524-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073524-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073524-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073524-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073524-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073524-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073524-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073524-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073524-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073524-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073524-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073524-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073524-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073524-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073524-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073524-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073524-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073524-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073524-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073524-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073524-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073524-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073524-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073524-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073524-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073524-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073524-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073524-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073524-001	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 5 · 90 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	52cf3ba9-0a7c-4809-830e-af93d1532726	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	American Health Packaging	7108d630-89bc-4815-b6fb-a1f4676c496e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	40bf2923-24b1-4af1-8d20-03cf06b455a5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	d0121be3-b904-41d3-a81a-292aa4176491	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Bionpharma Inc.,	138d9ed1-2f8e-d19d-e063-6394a90a695d	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb3	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Coupler LLC	5461e739-0f18-b012-e063-6394a90a6b14	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler LLC	544e3b55-c8a3-a480-e063-6394a90abbb5	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	cd8b51f4-8427-4b18-9d2c-10771d2a6580	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Ajanta Pharma USA Inc.	2e3c4854-89a1-4e3f-88d4-e164829585fb	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d3cd36c4-b25e-4716-be1d-0b2c83ea6a03	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	48080efd-1781-4585-83f8-c43957ac63b3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA,	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0778	Carbamazepine	Carbamazepine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51079-870	Carbamazepine	Carbamazepine	Mylan Institutional Inc.	ANDA	Current
51079-870	Carbamazepine	Carbamazepine	Mylan Institutional Inc.	ANDA	Current
63629-8743	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8743	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-9292	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current