Active ingredient
Tavaborole
8 finished FDA listings contain Tavaborole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TAVABOROLE
- Dosage forms
- Solution
- Routes
- Topical
- Manufacturers / labelers
- 8
- Strengths listed
- 43.5 mg/ml
- Brand names in FDA listings
- Tavaborole
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1543173
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 211297 | ENCUBE | 2020-10-13 | 2 |
| ANDA 212188 | ALEMBIC | 2020-10-21 | 2 |
| ANDA 211963 | CHARTWELL RX | 2021-02-03 | 1 |
| ANDA 212224 | CIPLA | 2021-02-09 | 1 |
| ANDA 212294 | ZYDUS LIFESCIENCES | 2023-04-10 | 2 |
Official labeling on DailyMed
- TAVABOROLE SOLUTION [CIPLA USA INC.] · version 3 · 2025-12-22
- TAVABOROLE (TAVABOROLE TOPICAL SOLUTION, 5%) SOLUTION [ENCUBE ETHICALS, INC.] · version 7 · 2025-09-17
- TAVABOROLE SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2025-02-21
- TAVABOROLE SOLUTION [ZYDUS LIFESCIENCES LIMITED] · version 2 · 2024-12-09
- TAVABOROLE SOLUTION [VIONA PHARMACEUTICALS INC] · version 2 · 2024-12-09
- TAVABOROLE SOLUTION [MAYNE PHARMA COMMERCIAL LLC] · version 4 · 2024-03-07
- TAVABOROLE SOLUTION [ALEMBIC PHARMACEUTICALS INC.] · version 8 · 2023-12-18
- TAVABOROLE SOLUTION [CHARTWELL RX, LLC] · version 1 · 2023-09-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.