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Active ingredient

Cyclophosphamide

87 finished FDA listings contain Cyclophosphamide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE ANHYDROUS
Dosage forms
Capsule, Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Injection, Solution, Concentrate, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
26
Strengths listed
1 g/2ml · 1 g/50ml · 1 g/5ml · 1000 mg/10ml · 2 g/100ml · 2 g/10ml · 2 g/4ml · 200 mg/ml · 2000 mg/20ml · 25 mg/1 · 50 mg/1 · 500 mg/2.5ml · 500 mg/25ml · 500 mg/5ml · 500 mg/ml
Brand names in FDA listings
Cyclophosphamide, Frindovyx

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3002

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 012141BAXTER HLTHCARE1959-11-162
ANDA 040745BAXTER HLTHCARE2008-05-2121
NDA 203856HIKMA2013-09-162
ANDA 204555HENGRUI PHARMA2014-10-319
ANDA 210046AMNEAL2018-05-253
ANDA 211608CIPLA2019-01-182
NDA 212501DR REDDYS2020-07-305
NDA 210735EUGIA PHARMA SPECLTS2021-08-253
ANDA 211757XGEN PHARMS2022-10-183
ANDA 215892ALEMBIC2022-11-104
NDA 210852AVYXA HOLDINGS2023-06-076
NDA 217651BAXTER HLTHCARE CORP2023-06-272
ANDA 214529SAGENT PHARMS INC2023-07-173
NDA 217150SANDOZ2023-09-123
ANDA 216783NEXUS2024-10-292
ANDA 218282EIRGEN2024-12-032
ANDA 218644EPIC PHARMA LLC2024-12-199
ANDA 218632HAINAN POLY2024-12-266

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

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