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FDA NDA · NDA217150

CYCLOPHOSPHAMIDE

Sponsor: SANDOZ

APPLICATION
NDA217150
TYPE
NDA
ORIGINAL APPROVAL
2023-09-12
LATEST ACTION
2024-12-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) · SOLUTION · INTRAVENOUS
CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) · SOLUTION · INTRAVENOUS
CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-12-30Labeling · Supplement 1 · standard — Label ↗AP
2023-09-12Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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