APPLICATION
NDA018057
TYPE
NDA
ORIGINAL APPROVAL
1978-12-19
LATEST ACTION
2022-03-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
PLATINOL-AQ · ReferenceDiscontinued
CISPLATIN 0.5MG/ML · INJECTABLE · INJECTION
PLATINOL · ReferenceDiscontinued
CISPLATIN 10MG/VIAL · INJECTABLE · INJECTION
CISPLATIN · ReferencePrescription
CISPLATIN 1MG/ML · INJECTABLE · INJECTION
CISPLATIN · ReferencePrescription
CISPLATIN 50MG/VIAL · INJECTABLE · INJECTION
Approval history
2017-01-19Manufacturing (CMC) · Supplement 86 · standardAP
2015-10-06Manufacturing (CMC) · Supplement 85 · standardAP
2015-03-03Manufacturing (CMC) · Supplement 84 · standardAP
2014-02-06Manufacturing (CMC) · Supplement 82 · standardAP
2001-01-16Manufacturing (CMC) · Supplement 75 · standardAP
2000-09-13Manufacturing (CMC) · Supplement 74 · standardAP
1999-05-05Labeling · Supplement 72 · standardAP
1996-04-18Manufacturing (CMC) · Supplement 66 · standardAP
1995-12-13Manufacturing (CMC) · Supplement 63 · standardAP
1995-12-04Manufacturing (CMC) · Supplement 64 · standardAP
1995-08-09Labeling · Supplement 65 · standardAP
1993-05-17Labeling · Supplement 62 · standardAP
1993-04-22Efficacy · Supplement 61 · unknownAP
1993-03-25Labeling · Supplement 60 · standardAP
1992-07-27Labeling · Supplement 56AP
1991-11-27Manufacturing (CMC) · Supplement 53 · standardAP
1991-11-01Manufacturing (CMC) · Supplement 59 · standardAP
1991-07-11Manufacturing (CMC) · Supplement 57 · standardAP
1990-12-11Labeling · Supplement 51AP
1990-09-27Manufacturing (CMC) · Supplement 55 · standardAP
1990-05-29Manufacturing (CMC) · Supplement 58 · standardAP
1990-04-04Manufacturing (CMC) · Supplement 52 · standardAP
1989-03-02Labeling · Supplement 49AP
1988-11-08Manufacturing (CMC) · Supplement 47 · standardAP
1988-05-05Manufacturing (CMC) · Supplement 44 · standardAP
1988-02-11Manufacturing (CMC) · Supplement 27 · standardAP
1988-01-13Manufacturing (CMC) · Supplement 45 · standardAP
1988-01-12Manufacturing (CMC) · Supplement 50 · standardAP
1987-06-08Manufacturing (CMC) · Supplement 40 · standardAP
1987-04-10Labeling · Supplement 46AP
1987-03-23Labeling · Supplement 43AP
1987-03-05Manufacturing (CMC) · Supplement 35 · standardAP
1986-11-06Labeling · Supplement 42AP
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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