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 1.

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 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091513-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2011-12-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A091513-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091513-001	AB	1	`cb3db0bc1861…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	c1c8bd8b-7ff8-5940-e053-2995a90ae656	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	REMEDYREPACK INC.	48d1b484-ee0a-4d66-9b45-4ba34e65ed13	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	095f54ba-4d43-4266-8942-eede6678ee3b	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Glenmark Pharmaceuticals Inc., USA	d5c837a4-d1c6-4615-b7ad-27f3162a03aa	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Chartwell RX, LLC	801f2143-6816-4f34-b65d-16bb2cf07975	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Golden State Medical Supply, Inc.	8e5e2b3a-467b-4312-9778-8ff2ce938838	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	832d1e92-1024-495a-bb7f-590412aae699	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	6303cf3c-175c-46ff-9b88-05f6ea7a2135	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Actavis Pharma, Inc.	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Major Pharmaceuticals	35ae4d64-4625-4fdd-a2d4-e20b87c56876	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Zameer Pharmaceuticals LLC	048b4bc7-c77e-40fc-9bfb-bb35c6a3f871	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Macleods Pharmaceuticals Limited	fcb13b21-e4a2-461b-b3cb-0daedc722050	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	dfc1af0b-b0e7-43fd-8da0-65281963bc3e	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1523cb4c-3a52-6c18-e063-6394a90a396f	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	871d70aa-4a7d-44dd-933c-969164b75942	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	2f431dd1-e130-45e5-a796-1662f498585e	2023-11-06	Warnings, Adverse reactions	Name fallback generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	1065cfd9-3d32-466c-8dff-c81eae1a0533	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE
Trospium Chloride	TROSPIUM CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	570c3ae7-8011-4944-8935-57d0a66102aa	2023-08-21	Warnings, Adverse reactions	Name fallback brand name: Trospium Chloride generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Granules Pharmaceuticals Inc.	5c088397-f407-4606-95a0-d9fe619888c3	2023-07-28	Warnings, Adverse reactions	Name fallback brand name: TROSPIUM CHLORIDE generic name: TROSPIUM CHLORIDE

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