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FDA ANDA · ANDA212559

IRON SUCROSE

Sponsor: MYLAN LABS LTD

APPLICATION
ANDA212559
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-08
LATEST ACTION
2025-08-08
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IRON SUCROSEPrescription
IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
IRON SUCROSEPrescription
IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
IRON SUCROSEPrescription
IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS

Approval history

2025-08-08UNKNOWN · Original · standardAP
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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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