APPLICATION
ANDA074735
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-16
LATEST ACTION
2020-10-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CISPLATINPrescription
CISPLATIN 1MG/ML · INJECTABLE · INJECTION
Approval history
2020-10-19Labeling · Supplement 13 · standardAP
2012-11-13Labeling · Supplement 11 · standardAP
2011-03-08Labeling · Supplement 10AP
2002-12-05Manufacturing (CMC) · Supplement 5AP
2002-02-22Manufacturing (CMC) · Supplement 4AP
2001-04-05Manufacturing (CMC) · Supplement 3AP
2000-05-16Manufacturing (CMC) · Supplement 1AP
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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