Active ingredient
Solifenacin
51 finished FDA listings contain Solifenacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SOLIFENACIN SUCCINATE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 20
- Strengths listed
- 10 mg/1 · 5 mg/1
- Brand names in FDA listings
- Solifenacin Succinate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 322167
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 210224 | ALKEM LABS LTD | 2019-05-20 | 11 |
| ANDA 211657 | SCIEGEN PHARMS | 2019-05-20 | 6 |
| ANDA 209333 | QILU | 2019-05-20 | 5 |
| ANDA 210281 | BOSTAL | 2019-05-20 | 4 |
| ANDA 202551 | WATSON LABS INC | 2019-05-20 | 3 |
| ANDA 209239 | GLENMARK SPECLT | 2019-05-20 | 2 |
| ANDA 210688 | MSN | 2019-05-20 | 2 |
| ANDA 205483 | AJANTA PHARMA LTD | 2019-05-20 | 2 |
| ANDA 205575 | ALEMBIC | 2019-05-20 | 4 |
| ANDA 211701 | UNICHEM | 2019-08-27 | 4 |
| ANDA 213346 | SUNSHINE | 2020-04-13 | 2 |
| ANDA 215761 | ANNORA PHARMA | 2022-06-15 | 2 |
| ANDA 206817 | AUROBINDO PHARMA | 2022-12-27 | 2 |
| ANDA 204374 | MACLEODS PHARMS | 2024-02-20 | 2 |
Official labeling on DailyMed
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [HEC PHARM USA INC.] · version 1 · 2026-07-09
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP] · version 1 · 2026-02-10
- SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCIATE) TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [BOSTAL LLC] · version 10 · 2026-02-06
- SOLIFENACIN SUCCINATE TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] · version 6 · 2026-01-29
- SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCIATE) TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AVKARE] · version 4 · 2026-01-16
- SOLIFENACIN SUCCINATE TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AJANTA PHARMA USA INC.] · version 8 · 2026-01-06
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [APOTEX CORP.] · version 7 · 2025-11-27
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 103 · 2025-11-17
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2025-11-17
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 105 · 2025-10-02
- SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 105 · 2025-09-11
Showing the 12 most recent of 31 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.