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FDA ANDA · ANDA219271

CYCLOPHOSPHAMIDE

Sponsor: HETERO LABS LIMITED

APPLICATION
ANDA219271
TYPE
ANDA
ROUTE
SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
None (Tentative Approval)

Products

CYCLOPHOSPHAMIDENone (Tentative Approval)
CYCLOPHOSPHAMIDE 500MG/2.5ML · INJECTION · SOLUTION
CYCLOPHOSPHAMIDENone (Tentative Approval)
CYCLOPHOSPHAMIDE 2000MG/10ML · INJECTION · SOLUTION

Approval history

2026-04-29UNKNOWN · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

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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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