Home Applications 091575 Application 091575
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET;ORAL 20MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091575-001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091575-001 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-461 Trospium Chloride Trospium Chloride Glenmark Pharmaceuticals Inc., USA ANDA Current 69150-258 Trospium Chloride Trospium Chloride BIOMES PHARMACEUTICALS LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9343 ORIG 2010-08-31