Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017057
Company: LIEBEL-FLARSHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYSTO-CONRAY IOTHALAMATE MEGLUMINE 43% Solution; Intravesical, Ureteral Prescription None No No
CYSTO-CONRAY II IOTHALAMATE MEGLUMINE 17.2% SOLUTION;INTRAVESICAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/17/1972 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/30/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/13/2002 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17057slr027ltr.pdf
10/27/1999 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/13/1995 SUPPL-25 Labeling

Label is not available on this site.

08/28/1992 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1992 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1990 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1989 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1987 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/28/1989 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/10/1989 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/08/1983 SUPPL-15 Labeling

Label is not available on this site.

09/06/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1976 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1976 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1976 SUPPL-10 Labeling

Label is not available on this site.

05/05/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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