APPLICATION
ANDA074656
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-16
LATEST ACTION
2023-10-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CISPLATINPrescription
CISPLATIN 1MG/ML · INJECTABLE · INJECTION
Approval history
2023-10-23Labeling · Supplement 20 · standardAP
2015-09-22Labeling · Supplement 15 · standardAP
2012-03-15Labeling · Supplement 12AP
2012-01-23Labeling · Supplement 10AP
2008-10-17Labeling · Supplement 6AP
2002-07-17Manufacturing (CMC) · Supplement 1AP
2002-07-01Manufacturing (CMC) · Supplement 2AP
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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