Home Applications 205032 Application 205032
Type ANDA
Sponsor SUN PHARM INDS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG No No 002 FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG No No
Source provenance: Browse the complete Orange Book source catalog .
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 ยท 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fesoterodine Fumarate FESOTERODINE FUMARATE Ascend Laboratories, LLC b1abd9cb-c480-437b-8531-e2de3e188363 2026-07-16 Warnings, Adverse reactions Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE Toviaz FESOTERODINE FUMARATE Pfizer Laboratories Div Pfizer Inc 5be745f0-8ae7-4c3c-9962-37d6263326f1 2026-04-07 Warnings, Adverse reactions Name fallback generic name: FESOTERODINE FUMARATE Fesoterodine fumarate FESOTERODINE FUMARATE Golden State Medical Supply, Inc. e5e6e146-d39a-471c-e053-2995a90a7538 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Fesoterodine fumarate generic name: FESOTERODINE FUMARATE Fesoterodine fumarate FESOTERODINE FUMARATE Dr.Reddy's Laboratories Inc., 5c5d2a97-9029-744f-c410-a4bbbe9761a8 2025-09-01 Warnings, Adverse reactions Name fallback brand name: Fesoterodine fumarate generic name: FESOTERODINE FUMARATE Fesoterodine Fumarate FESOTERODINE FUMARATE Alembic Pharmaceuticals Inc. 299db62d-9658-4796-b449-657fa859c5cd 2025-06-17 Warnings, Adverse reactions Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE FESOTERODINE FUMARATE FESOTERODINE FUMARATE NorthStar RxLLC cb597206-1c75-4a4f-a17a-524a2010a4b9 2025-03-05 Warnings, Adverse reactions Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE FESOTERODINE FUMARATE FESOTERODINE FUMARATE Camber Pharmaceuticals, Inc. dc532c6c-ff0d-488a-8a92-b1b0f37c944e 2025-03-04 Warnings, Adverse reactions Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE fesoterodine fumarate FESOTERODINE FUMARATE Zydus Pharmaceuticals USA Inc. 8c68e918-b47b-466d-80bc-4f521aa74607 2025-01-01 Warnings, Adverse reactions Name fallback brand name: fesoterodine fumarate generic name: FESOTERODINE FUMARATE FESOTERODINE FUMARATE FESOTERODINE FUMARATE Aurobindo Pharma Limited dc8f6158-3c2b-4ec0-a951-e04468b83bb1 2024-12-02 Warnings, Adverse reactions Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE fesoterodine fumarate FESOTERODINE FUMARATE Zydus Lifesciences Limited 26e8cc63-1e1d-4a77-8f53-4c38bcf0d443 2024-11-30 Name fallback brand name: fesoterodine fumarate generic name: FESOTERODINE FUMARATE Fesoterodine Fumarate FESOTERODINE FUMARATE Amneal Pharmaceuticals LLC 1d3fdfcf-7406-4be0-90e9-b10c9257bf69 2024-04-12 Warnings, Adverse reactions Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE Fesoterodine Fumarate FESOTERODINE FUMARATE Alembic Pharmaceuticals Limited 571147f2-e182-44b5-9d0b-ecfc3265cc2d 2023-01-30 Warnings, Adverse reactions Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE