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FDA ANDA · ANDA208075

CEFTAROLINE FOSAMIL

Sponsor: APOTEX

APPLICATION
ANDA208075
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-21
LATEST ACTION
2024-05-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

CEFTAROLINE FOSAMILPrescription
CEFTAROLINE FOSAMIL 600MG/VIAL · POWDER · INTRAVENOUS
CEFTAROLINE FOSAMILPrescription
CEFTAROLINE FOSAMIL 400MG/VIAL · POWDER · INTRAVENOUS

Approval history

2024-05-30Labeling · Supplement 1 · standardAP
2024-05-30Labeling · Supplement 2 · standardAP
2021-09-21UNKNOWN · Original · standardLetterAP
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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