Active ingredient
Botulinum Toxin Type A
20 finished FDA listings contain Botulinum Toxin Type A as their only active ingredient; 9 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BOTULINUM TOXIN TYPE A, LETIBOTULINUMTOXINA
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Powder
- Routes
- Intradermal, Intramuscular
- Manufacturers / labelers
- 9
- Strengths listed
- 100 [usp'u]/1 · 100 u/1 · 100 u/1.2ml · 200 [usp'u]/1 · 300 u/1 · 50 [usp'u]/1 · 50 u/1 · 500 u/1
- Brand names in FDA listings
- Botox, Botox Cosmetic, Daxxify, Dysport, Jeuveau, Letybo, Xeomin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1712
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 |
|---|---|---|---|
| BLA 103000 | ALLERGAN | 1991-12-09 | 5 |
| BLA 125274 | IPSEN BIOPHARM LTD | 2009-04-29 | 3 |
| BLA 125360 | MERZ PHARMS | 2010-07-30 | 8 |
| BLA 761085 | EVOLUS INC | 2019-02-01 | 1 |
| BLA 761127 | REVANCE THERAPEUTICS, INC. | 2022-09-07 | 1 |
| BLA 761225 | HUGEL INC | 2024-02-29 | 2 |
Official labeling on DailyMed
- BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.] · version 62 · 2026-08-03
- XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] · version 27 · 2026-07-13
- XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ PHARMACEUTICALS, LLC] · version 34 · 2026-07-13
- BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SPORTPHARM LLC] · version 1 · 2026-02-06
- BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.] · version 54 · 2026-01-08
- DAXXIFY (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVANCE THERAPEUTICS, INC.] · version 12 · 2026-01-08
- LETYBO (LETIBOTULINUMTOXINA-WLBG) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUGEL, INC.] · version 4 · 2024-11-27
- DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] · version 12 · 2024-10-28
- JEUVEAU (PRABOTULINUM TOXIN TYPE A) POWDER [EVOLUS, INC.] · version 8 · 2023-12-14
- DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] · version 25 · 2023-09-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.