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 42.

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
2026-08-18 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 1 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	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	Umedica Laboratories USA Inc.	48080efd-1781-4585-83f8-c43957ac63b3	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	52cf3ba9-0a7c-4809-830e-af93d1532726	2026-08-04	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	REMEDYREPACK INC.	9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2	2026-07-29	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	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	40bf2923-24b1-4af1-8d20-03cf06b455a5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	d0121be3-b904-41d3-a81a-292aa4176491	2026-07-06	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	REMEDYREPACK INC.	8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb3	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE