Application 219072

Type: ANDA
Sponsor: YICHANG HUMANWELL

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 43.

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
A219072-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16
A219072-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16
A219072-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219072-001	AB
A219072-002	AB
A219072-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219072-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219072-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219072-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219072-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219072-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219072-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219072-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219072-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219072-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219072-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219072-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219072-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219072-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219072-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219072-003	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219072-003	AB	1	`a50c72e98297…`

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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d3cd36c4-b25e-4716-be1d-0b2c83ea6a03	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine ER	CARBAMAZEPINE	Oryza Pharmaceuticals Inc.	34b375d0-68b0-4bd5-8ac9-be043b57e91c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	62d38b93-7dd0-48e7-bd59-a434d52520f6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Major Pharmaceuticals	2676f950-48b4-4bef-a792-ea4570de9aa6	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE ER	CARBAMAZEPINE	Bostal LLC	b48741b3-0889-47b8-a26e-b12614f6e7fc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	NuCare Pharmaceuticals, Inc.	509bd024-9944-a2f3-e063-6394a90ae4cb	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Cardinal Health 107, LLC	232ef732-ee6d-4ac7-8e78-c619b611fbbe	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	20cd4276-afb1-43e5-abb3-e2af7f8a71dd	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	3207764f-0663-477e-ad1f-f5fb43b6bbf3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	ANI Pharmaceuticals, Inc.	c1876184-0323-4b06-b459-603b40c0c002	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	34f57a68-57ad-57f1-e063-6394a90a3d33	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	32dc301e-881d-47b0-ad16-f9ff31d19324	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Northstar Rx LLC	b563e4a1-d7dd-4901-ad45-614f85687589	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	536811ab-308b-4866-9185-9e4149483512	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	1922a7cd-6a43-dab5-e063-6294a90a3d8f	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	8a1ce79d-18ea-f30b-e053-2995a90ad1fb	2026-02-12	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.