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FDA ANDA · ANDA205487

CARBOPLATIN

Sponsor: EUGIA PHARMA

APPLICATION
ANDA205487
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-28
LATEST ACTION
2016-03-28
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CARBOPLATINPrescription
CARBOPLATIN 600MG/60ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 150MG/15ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 450MG/45ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 50MG/5ML (10MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2016-03-28UNKNOWN · 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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