Home Applications 020771 Application 020771
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DETROL TOLTERODINE TARTRATE TABLET;ORAL 1MG Yes No 002 DETROL TOLTERODINE TARTRATE TABLET;ORAL 2MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020771-001 DETROL TOLTERODINE TARTRATE 1MG TABLET / ORAL AB RLD 1998-03-25 N020771-002 DETROL TOLTERODINE TARTRATE 2MG TABLET / ORAL AB RLD, RS 1998-03-25
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 3 · 86 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 2026-09-14 22:38:34 2026-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Detrol TOLTERODINE TARTRATE Viatris Specialty LLC 41eb00d2-64e3-4ec9-8732-4bfc81b04180 2023-02-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 020771 application number: NDA020771
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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-4541 Detrol tolterodine tartrate Pharmacia & Upjohn Company LLC NDA Current 0009-4541 Detrol tolterodine tartrate Pharmacia and Upjohn Company LLC NDA Current 0009-4544 Detrol tolterodine tartrate Pharmacia & Upjohn Company LLC NDA Current 0009-4544 Detrol tolterodine tartrate Pharmacia and Upjohn Company LLC NDA Current 0093-2055 Tolterodine Tartrate Tolterodine Tartrate Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-2056 Tolterodine Tartrate Tolterodine Tartrate Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 59762-0170 Tolterodine Tartrate Tolterodine Tartrate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-0800 Tolterodine Tartrate Tolterodine Tartrate Greenstone LLC NDA AUTHORIZED GENERIC Current 70518-1416 Tolterodine Tartrate Tolterodine Tartrate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1416 Tolterodine Tartrate Tolterodine Tartrate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1416 Tolterodine Tartrate Tolterodine Tartrate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1416 Tolterodine Tartrate Tolterodine Tartrate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1416 Tolterodine Tartrate Tolterodine Tartrate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current