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FDA NDA · NDA212501

CYCLOPHOSPHAMIDE

Sponsor: DR REDDYS

APPLICATION
NDA212501
TYPE
NDA
ORIGINAL APPROVAL
2020-07-30
LATEST ACTION
2025-03-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) · SOLUTION · INTRAVENOUS
CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) · SOLUTION · INTRAVENOUS
CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-03-11Labeling · Supplement 7 · standard — Letter ↗AP
2021-11-19Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2021-09-09Labeling · Supplement 2 · standard — Label ↗AP
2020-07-30Type 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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