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FDA NDA · NDA203856

CYCLOPHOSPHAMIDE

Sponsor: HIKMA

APPLICATION
NDA203856
TYPE
NDA
ORIGINAL APPROVAL
2013-09-16
LATEST ACTION
2019-09-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 50MG · CAPSULE · ORAL
CYCLOPHOSPHAMIDE · ReferencePrescription
CYCLOPHOSPHAMIDE 25MG · CAPSULE · ORAL

Approval history

2019-09-26Labeling · Supplement 3 · standard — Letter ↗AP
2013-09-16Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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