APPLICATION
ANDA075036
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-07
LATEST ACTION
2018-09-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CISPLATINPrescription
CISPLATIN 1MG/ML · INJECTABLE · INJECTION
Approval history
2018-09-24Labeling · Supplement 12 · standardAP
2012-03-15Labeling · Supplement 11AP
2012-01-30Labeling · Supplement 9AP
2011-03-08Labeling · Supplement 6AP
2004-06-21Labeling · Supplement 3AP
2004-06-21Supplement · Supplement 2AP
2001-05-14Manufacturing (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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