Application 215664

Type: ANDA
Sponsor: OSMOTICA PHARM US

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	Approval date
A215664-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	2024-10-22
A215664-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	2024-10-22
A215664-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	2024-10-22

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	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-22	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215664-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215664-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215664-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2024-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215664-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215664-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215664-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215664-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215664-003	AB	1	`d8e5a09893c0…`

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 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	2d2c5317-4072-477b-a4e2-f6765fc71657	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
EQUETRO	CARBAMAZEPINE	Validus Pharmaceuticals LLC	be478f3c-40f6-47cc-8ab9-f420a9372b1c	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	46eef194-760d-43ea-86c5-341927277c91	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	45b355e6-9c19-4138-a1f8-53508e88f5a9	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	4db57051-13bb-4038-ae58-e4d7f541450d	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Alembic Pharmaceuticals Limited	1fc170d7-db1a-486d-8c10-faa6e3da3b1e	2025-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	34f75728-b9e8-48e7-e063-6394a90afc31	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33ed4e35-8be2-d0ea-e063-6394a90a06a6	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33edb22f-f357-ec0f-e063-6394a90a7bc3	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Alembic Pharmaceuticals Limited	a742c03d-10b1-48e2-8df1-48967395ae06	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler, LLC	30b75584-3a1c-c125-e063-6294a90acaa7	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Atlantic Biologicals Corps	25939406-a836-43cd-9301-56808e9b31ec	2025-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	047bc284-060a-4db9-bf37-75d10f95a0a6	2025-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Coupler LLC	2d936849-9c80-5b7f-e063-6294a90aaa6c	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	direct rx	b56dd9c8-1bca-21e3-e053-2995a90a3e6e	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	ebcffad6-da03-43f4-a75b-7de13e94bb7d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Chartwell RX, LLC	8d5ace90-983b-48c4-baf1-b44f6af146de	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	697f3e5a-c84b-44a6-b9f3-15e7d9bb6395	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Upsher-Smith Laboratories, LLC	282c954f-e34a-4bd5-b5eb-771e3c56936f	2023-10-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Proficient Rx LP	bf61798e-c07e-4959-909a-2b4c2c83b532	2019-10-01	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.