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Active ingredient

Palonosetron

19 finished FDA listings contain Palonosetron as their only active ingredient; 3 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PALONOSETRON, PALONOSETRON HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
16
Strengths listed
.05 mg/ml · .075 mg/1.5ml · .25 mg/5ml
Brand names in FDA listings
Palonosetron, Posfrea

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 70561

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.

ApplicationSponsorOriginal approvalListings
NDA 021372HELSINN HLTHCARE2003-07-251
ANDA 202521SANDOZ2015-10-131
NDA 203050AVYXA HOLDINGS2016-03-011
ANDA 201533DR REDDYS2016-04-213
ANDA 090713TEVA PHARMS USA2018-03-231
ANDA 206416MYLAN INSTITUTIONAL2018-09-191
ANDA 204289SAGENT PHARMS INC2018-09-191
ANDA 205648QILU PHARM HAINAN2018-09-195
ANDA 206801FRESENIUS KABI USA2018-09-191
ANDA 206802FRESENIUS KABI USA2018-09-191
ANDA 204702EUGIA PHARMA2018-11-061
ANDA 206916BAXTER HLTHCARE CORP2021-11-121
ANDA 215861MEITHEAL2023-08-141

Official labeling on DailyMed

Showing the 12 most recent of 18 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.