Active ingredient
Sincalide
4 finished FDA listings contain Sincalide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SINCALIDE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 5 ug/5ml
- Brand names in FDA listings
- Kinevac
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9800
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 |
|---|---|---|---|
| NDA 017697 | BRACCO | 1976-07-21 | 2 |
| NDA 210850 | MAIA PHARMS INC | 2022-11-22 | 2 |
Official labeling on DailyMed
- SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC] · version 3 · 2024-05-16
- SINCALIDE (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 3 · 2024-01-31
- SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.] · version 4 · 2023-11-02
- KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.] · version 13 · 2023-10-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.