Home Applications 210775 Application 210775
Type ANDA
Sponsor INVATECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG No No 002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A210775-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 A210775-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 80 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 2026-10-15 13:18:30 2026-09 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210775-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2019-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210775-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2019-12-30 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 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 · 17 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tolterodine Tartrate TOLTERODINE TARTRATE Slate Run Pharmaceuticals, LLC bbbee85a-e5e2-24ec-e053-2995a90acfd8 2026-08-05 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Major Pharmaceuticals e4b9ef09-c750-4e35-96fc-e759ba4849d8 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE TOLTERODINE TARTRATE TOLTERODINE Torrent Pharmaceuticals Limited db6e0b6d-0ce5-41d7-881f-881c11f530a4 2026-02-09 Warnings, Adverse reactions Name fallback brand name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE A-S Medication Solutions fd6c8b3d-a52a-4418-aa9c-0297db6c0807 2026-01-09 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Golden State Medical Supply, Inc. 05b92da2-923b-3c04-e063-6394a90a69a1 2026-01-06 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine tartrate TOLTERODINE TARTRATE Ajanta Pharma USA Inc. fcaca033-cd08-4b8c-9bad-7b6751faf2c9 2025-11-03 Warnings, Adverse reactions Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE ANI Pharmaceuticals, Inc. fc5bdc4a-a483-4d31-807b-c7f8d8869723 2025-04-01 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Rising Pharma Holdings, Inc. b9ba8ad2-27f6-4f18-bd84-73659047910e 2025-04-01 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Teva Pharmaceuticals USA, Inc. 973f98b5-4e8a-42d9-ac69-d4333d21c362 2024-09-25 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine tartrate TOLTERODINE TARTRATE Unichem Pharmaceuticals (USA), Inc. 9710ad7b-93c2-4ec1-95ff-597563be4314 2024-09-03 Warnings, Adverse reactions Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE Detrol TOLTERODINE TARTRATE Viatris Specialty LLC 41eb00d2-64e3-4ec9-8732-4bfc81b04180 2023-02-15 Warnings, Adverse reactions Name fallback generic name: TOLTERODINE TARTRATE Tolterodine tartrate TOLTERODINE TARTRATE Macleods Pharmaceuticals Limited 3f2291c3-7e3c-41be-afa6-ef73ce896e30 2022-11-19 Warnings, Adverse reactions Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Teva Pharmaceuticals USA, Inc. d27e25b5-5d02-419f-b098-41fb162c5872 2022-10-11 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Camber Pharmaceuticals, Inc. f67fce7c-69d3-42ae-8c1d-2e26fd4d7415 2021-08-16 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Unichem Pharmaceuticals (USA), Inc. 56e62829-5371-416a-90b3-4b6429532d25 2020-08-07 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Proficient Rx LP b77f9893-a422-423a-bb27-527377ade36d 2019-10-01 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE Tolterodine Tartrate TOLTERODINE TARTRATE Camber Pharmaceuticals, Inc. e16012ae-5972-470b-8a22-b0626a029e95 2017-06-03 Warnings, Adverse reactions Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10135-706 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 10135-706 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 10135-706 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 10135-707 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 10135-707 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 10135-707 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Marlex Pharmaceuticals Inc ANDA Current 73152-026 Tolterodine Tartrate Tolterodine Tartrate Athem LLC ANDA Current 73152-026 Tolterodine Tartrate Tolterodine Tartrate Athem LLC ANDA Current 73152-027 Tolterodine Tartarate Tolterodine Tartarate Athem LLC ANDA Current 73152-027 Tolterodine Tartarate Tolterodine Tartarate Athem LLC ANDA Current