Application 205550

Type: ANDA
Sponsor: JUBILANT GENERICS

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 1.

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
A205550-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2016-10-12
A205550-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL			2016-10-12

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 · 82 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	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205550-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205550-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2016-10-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205550-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205550-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205550-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205550-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205550-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205550-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205550-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205550-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205550-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205550-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205550-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205550-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205550-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205550-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205550-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205550-002	AB	1	`ea99ee380514…`

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 HYDROBROMIDE	Cipla USA Inc.	6e8470d1-c3e6-4644-b70a-aa47ddf79676	2025-10-27	Warnings, Adverse reactions	Name fallback generic name: DARIFENACIN HYDROBROMIDE
Darifenacin	DARIFENACIN HYDROBROMIDE	POLYGEN PHARMACEUTICALS INC.	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: DARIFENACIN HYDROBROMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-516	darifenacin	darifenacin hydrobromide	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-516	darifenacin	darifenacin hydrobromide	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-517	darifenacin	darifenacin hydrobromide	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-517	darifenacin	darifenacin hydrobromide	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current