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© 2026 Prognia · Amsterdam, the NetherlandsPrivacy TermsExchangeRate-API

Medicines · US (FDA)

FDA 2026

FDA

Cyclophosphamide

Approved 29 Apr 2026SolutionInjection

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: CYCLOPHOSPHAMIDE 2000MG/10ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA211757-002 · Prescription
CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA211757-003 · Prescription
CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA211757-001 · Prescription
CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA218644-003 · Prescription
CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA218644-001 · Prescription
CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA218644-002 · Prescription
CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA214529-002 · Prescription
CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA214529-003 · Prescription
CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA214529-001 · Prescription
CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA216958-003 · Prescription
CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA216958-001 · Prescription
CYCLOPHOSPHAMIDE 1GM/VIAL · Injectable

At a glance

Brand name: Cyclophosphamide
Route: Solution
Dosage form: Injection
Applicant: Hetero Labs Limited
Status: Tentative approval
FDA approval: 29 Apr 2026
Application: ANDA219271-003

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA216958-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA218282-001 · Prescription

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA218282-002 · Prescription

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA209872-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA209872-001 · Prescription

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA211608-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA211608-001 · Prescription

CYCLOPHOSPHAMIDE 200MG/VIAL · InjectableANDA088372-001 · Discontinued

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA215892-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA215892-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) · SolutionNDA217150-002 · Prescription

CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) · SolutionNDA217150-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) · SolutionNDA217150-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) · SolutionNDA217651-002 · Prescription

CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) · SolutionNDA217651-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA204555-002 · Prescription

CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA204555-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA204555-001 · Prescription

CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) · SolutionNDA212501-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) · SolutionNDA212501-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) · SolutionNDA212501-002 · Prescription

CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) · SolutionANDA216783-002 · Prescription

CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) · SolutionANDA216783-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA088374-001 · Discontinued

CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) · SolutionNDA210735-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) · SolutionNDA210735-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) · SolutionNDA210735-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA211552-001 · Prescription

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA211552-002 · Prescription

CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA088373-001 · Discontinued

CYCLOPHOSPHAMIDE 50MG · CapsuleANDA207014-002 · Discontinued

CYCLOPHOSPHAMIDE 25MG · CapsuleANDA207014-001 · Discontinued

CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA218632-003 · Discontinued

CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA218632-001 · Discontinued

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA218632-002 · Discontinued

CYCLOPHOSPHAMIDE 50MG · TabletANDA040032-002 · Discontinued

CYCLOPHOSPHAMIDE 25MG · TabletANDA040032-001 · Discontinued

CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA040745-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA040745-001 · Prescription

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA040745-002 · Prescription

CYCLOPHOSPHAMIDE 100MG/VIAL · InjectableANDA088371-001 · Discontinued

CYCLOPHOSPHAMIDE 1GM/VIAL · InjectableANDA215089-002 · Prescription

CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA215089-003 · Prescription

CYCLOPHOSPHAMIDE 500MG/VIAL · InjectableANDA215089-001 · Prescription

CYCLOPHOSPHAMIDE 500MG/2.5ML · InjectionANDA219271-002 · Tentative approval

CYCLOPHOSPHAMIDE 2000MG/10ML · InjectionThis page

CYCLOPHOSPHAMIDE 50MG · CapsuleNDA203856-002 · Prescription

CYCLOPHOSPHAMIDE 25MG · CapsuleNDA203856-001 · Prescription

CYCLOPHOSPHAMIDE 2GM/VIAL · InjectableANDA210046-003 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA219271.

Open Drugs@FDA

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.