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FDA NDA · NDA017057
CYSTO-CONRAY II
iothalamate meglumine
Sponsor: LIEBEL-FLARSHEIM
APPLICATION
NDA017057
TYPE
NDA
ORIGINAL APPROVAL
1972-04-17
LATEST ACTION
2013-12-19
ROUTE
URETERAL, INTRAVESICAL, Intravesical, Ureteral
DOSAGE FORM
SOLUTION, Solution
MARKETING STATUS
Prescription
Products
CYSTO-CONRAY IIPrescription
IOTHALAMATE MEGLUMINE 17.2% · SOLUTION · INTRAVESICAL
CYSTO-CONRAYPrescription
IOTHALAMATE MEGLUMINE 43% · Solution · Intravesical, Ureteral
Approval history
2013-12-19Manufacturing (CMC) · Supplement 31 · standardAP
2013-05-30Manufacturing (CMC) · Supplement 29 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 28 · standardAP
1999-10-27Manufacturing (CMC) · Supplement 26 · standardAP
1995-01-13Labeling · Supplement 25 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 23 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 24 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 22 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 21 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 18 · standardAP
1989-06-28Manufacturing (CMC) · Supplement 19 · standardAP
1987-07-08Manufacturing (CMC) · Supplement 20 · standardAP
1984-12-04Manufacturing (CMC) · Supplement 17 · standardAP
1984-06-26Manufacturing (CMC) · Supplement 16 · standardAP
1983-07-08Labeling · Supplement 15AP
1978-09-06Manufacturing (CMC) · Supplement 13 · standardAP
1976-09-14Manufacturing (CMC) · Supplement 11 · standardAP
1976-09-14Manufacturing (CMC) · Supplement 12 · standardAP
1976-05-05Manufacturing (CMC) · Supplement 9 · standardAP
1976-05-05Labeling · Supplement 10AP
1976-01-23Manufacturing (CMC) · Supplement 7 · standardAP
1976-01-23Manufacturing (CMC) · Supplement 8 · standardAP
1975-07-30Manufacturing (CMC) · Supplement 6 · standardAP
1972-04-17Type 3 - New Dosage Form · 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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