Medicine
Fesoterodine 8 mg extended-release tablet
Fesoterodine 8 mg extended-release tablet is a generic prescription medicine for oral use, made by 9 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Fesoterodine
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 90 tablets and 22 more
- Manufacturers
- Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaAmneal PharmaceuticalsGolden State Medical SupplyNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD11 Fesoterodine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 December 2017
- Identifiers
- RxCUI 810071, 810077DailyMed set ID 571147f2-e182-44b5-9d0b-ecfc3265cc2d, e5e6e146-d39a-471c-e053-2995a90a7538, b1abd9cb-c480-437b-8531-e2de3e188363 +8NDC 46708-176, 51407-662, 67877-068 +8Application ANDA204973, ANDA204975, ANDA204827 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, extended release in 1 carton | 46708-176-10 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 30 tablet, extended release in 1 bottle | 46708-176-30 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 90 tablet, extended release in 1 bottle | 46708-176-90 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 1000 tablet, extended release in 1 bottle | 46708-176-91 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 100 tablet, extended release in 1 carton | 62332-176-10 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 30 tablet, extended release in 1 bottle | 62332-176-30 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 90 tablet, extended release in 1 bottle | 62332-176-90 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 1000 tablet, extended release in 1 bottle | 62332-176-91 | Alembic PharmaceuticalsIndia | 6 January 2023 |
| 30 tablet, film coated, extended release in 1 bottle | 68382-480-06 | Zydus LifesciencesIndia | 7 December 2017 |
| 90 tablet, film coated, extended release in 1 bottle | 68382-480-16 | Zydus LifesciencesIndia | 7 December 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 68382-480-77 | Zydus LifesciencesIndia | 7 December 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 70771-1169-3 | Zydus LifesciencesIndia | 7 December 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 70771-1169-4 | Zydus LifesciencesIndia | 7 December 2017 |
| 90 tablet, film coated, extended release in 1 bottle | 70771-1169-9 | Zydus LifesciencesIndia | 7 December 2017 |
| 30 tablet, extended release in 1 bottle | 67877-068-30 | Ascend LaboratoriesIndia | 9 June 2022 |
| 90 tablet, extended release in 1 bottle | 67877-068-90 | Ascend LaboratoriesIndia | 9 June 2022 |
| 30 tablet, film coated, extended release in 1 bottle | 65862-767-30 | Aurobindo PharmaIndia | 17 June 2022 |
| 30 tablet, film coated, extended release in 1 bottle | 31722-034-30 | Camber PharmaceuticalsIndia | 9 January 2024 |
| 90 tablet, film coated, extended release in 1 bottle | 31722-034-90 | Camber PharmaceuticalsIndia | 9 January 2024 |
| 30 tablet, extended release in 1 bottle | 43598-248-30 | Dr. Reddy's LaboratoriesIndia | 10 June 2022 |
| 90 tablet, extended release in 1 bottle | 43598-248-90 | Dr. Reddy's LaboratoriesIndia | 10 June 2022 |
| 30 tablet, extended release in 1 bottle | 65162-370-03 | Amneal Pharmaceuticals | 6 January 2023 |
| 90 tablet, extended release in 1 bottle | 65162-370-09 | Amneal Pharmaceuticals | 6 January 2023 |
| 30 tablet, extended release in 1 bottle | 51407-662-30 | Golden State Medical Supply | 7 July 2022 |
| 30 tablet, film coated, extended release in 1 bottle | 72603-414-01 | NorthStar RxLLC | 1 May 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fesoterodine 8 mg extended-release tablet.
Other strengths and forms of Fesoterodine
Clinical summary
Fesoterodine is a prescription medicine indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency, among other approved uses. It is available as extended-release tablets for oral use. MedsAcross supplies Fesoterodine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FesoterodineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Toviaz prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Toviaz: European public assessment report (EPAR) · European Medicines Agency
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