APPLICATION
NDA017788
TYPE
NDA
ORIGINAL APPROVAL
1978-04-04
LATEST ACTION
2015-08-27
ROUTE
INTRAVESICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
RIMSO-50 · ReferencePrescription
DIMETHYL SULFOXIDE 50% · SOLUTION · INTRAVESICAL
Approval history
2015-08-27Manufacturing (CMC) · Supplement 23 · standardAP
2014-08-28Manufacturing (CMC) · Supplement 22 · standardAP
2013-06-26Manufacturing (CMC) · Supplement 21 · standardAP
2008-07-28Manufacturing (CMC) · Supplement 19AP
2000-05-04Manufacturing (CMC) · Supplement 16 · standardAP
1995-03-02Manufacturing (CMC) · Supplement 12 · standardAP
1989-09-26Manufacturing (CMC) · Supplement 11 · standardAP
1989-02-23Manufacturing (CMC) · Supplement 10 · standardAP
1988-10-12Manufacturing (CMC) · Supplement 9 · standardAP
1980-09-29Labeling · Supplement 1AP
1980-09-29Labeling · Supplement 2AP
1978-04-04Type 1 - New Molecular Entity · Original · standardAP
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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