Active ingredient
Pralatrexate
6 finished FDA listings contain Pralatrexate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PRALATREXATE
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 20 mg/ml · 40 mg/2ml
- Brand names in FDA listings
- Folotyn
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 662019
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 022468 | ACROTECH BIOPHARMA | 2009-09-24 | 4 |
| ANDA 206183 | DR REDDYS | 2025-03-10 | 2 |
Official labeling on DailyMed
- PRALATREXATE INJECTION [DR.REDDY'S LABORATORIES INC.,] · version 6 · 2026-03-05
- PRALATREXATE INJECTION [FRESENIUS KABI USA, LLC] · version 1 · 2022-11-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.