Application 207681

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 7.5MG BASE	No	No
002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 15MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207681-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-12-08
A207681-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207681-001	AB
A207681-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207681-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207681-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-12-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207681-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207681-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207681-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207681-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207681-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207681-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207681-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207681-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207681-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207681-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207681-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207681-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207681-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207681-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207681-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207681-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207681-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207681-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207681-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207681-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207681-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207681-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207681-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207681-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207681-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207681-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207681-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207681-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207681-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207681-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207681-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207681-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207681-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207681-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207681-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207681-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207681-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207681-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207681-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207681-002	AB	1	`bb7c543d1eb4…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Limited	da7c2732-232c-4e71-92d9-577ef8617f56	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207681 application number: ANDA207681 ndc (product): 46708-224 ndc (product): 46708-223
DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	9f6952c8-e547-4f3e-a978-a88d6ea9dc10	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207681 application number: ANDA207681 ndc (product): 62332-223 ndc (product): 62332-224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Limited	ANDA	Current
46708-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Limited	ANDA	Current
46708-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Limited	ANDA	Current
46708-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Limited	ANDA	Current
62332-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-223	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-224	DARIFENACIN	DARIFENACIN	Alembic Pharmaceuticals Inc.	ANDA	Current