Application 091513

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091513-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB		2011-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091513-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091513-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091513-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091513-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091513-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091513-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091513-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091513-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091513-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091513-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091513-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091513-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091513-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091513-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091513-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091513-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091513-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091513-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091513-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091513-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091513-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091513-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091513-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091513-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091513-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091513-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091513-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091513-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091513-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091513-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091513-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091513-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091513-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091513-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091513-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091513-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091513-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091513-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091513-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091513-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091513-001	AB	1	`f41ea6bd6efb…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Padagis US LLC	bb3284ee-3d13-41c7-8e4b-f9b2d44350da	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride ER	TROSPIUM CHLORIDE	Padagis US LLC	4574f905-a8c5-4732-b934-d1c7f9e708c9	2022-11-30	Warnings, Adverse reactions	Name fallback generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Proficient Rx LP	5d0390ff-185d-41a7-9495-bb8006a05def	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Exelan Pharmaceuticals Inc.	a4108873-d2d2-4667-b049-02b89b8f2494	2020-09-22	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	CIPLA USA INC.,	6a711666-9e80-4728-b745-e7dc86f57510	2020-09-03	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bluepoint Laboratories	ed27c30d-c83a-45af-9c47-807da858d696	2020-07-08	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42291-846	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	AvKARE, Inc.	ANDA	Current
42291-846	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	AvKARE	ANDA	Current
60505-3454	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Apotex Corp.	ANDA	Current
60505-3454	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Apotex Corp.	ANDA	Current