Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013295
Company: LIEBEL-FLARSHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONRAY IOTHALAMATE MEGLUMINE 60% INJECTABLE;INJECTION Prescription None Yes Yes
CONRAY 43 IOTHALAMATE MEGLUMINE 43% INJECTABLE;INJECTION Discontinued None Yes 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
08/16/1962 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013295s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf
06/22/2016 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

07/06/2015 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/013295Orig1s068,016983Orig1s035ltr.pdf
02/03/2015 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/08/2014 SUPPL-66 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/013295Orig1s066ltr.pdf
02/25/2014 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

07/23/2013 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

05/30/2013 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/13/2003 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13295slr060ltr.pdf
02/26/2001 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1999 SUPPL-58 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/13/1995 SUPPL-57 Labeling

Label is not available on this site.

08/28/1992 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1992 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1990 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1989 SUPPL-53 Labeling

Label is not available on this site.

12/01/1989 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1988 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1989 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1986 SUPPL-49 Labeling

Label is not available on this site.

04/08/1985 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/1985 SUPPL-47 Efficacy

Label is not available on this site.

10/25/1984 SUPPL-46 Labeling

Label is not available on this site.

09/12/1984 SUPPL-45 Labeling

Label is not available on this site.

06/28/1989 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/10/1989 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1984 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1984 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/19/1984 SUPPL-40 Labeling

Label is not available on this site.

10/20/1982 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1982 SUPPL-38 Labeling

Label is not available on this site.

01/26/1983 SUPPL-36 Labeling

Label is not available on this site.

02/25/1983 SUPPL-34 Labeling

Label is not available on this site.

01/26/1983 SUPPL-33 Efficacy

Label is not available on this site.

12/07/1979 SUPPL-32 Labeling

Label is not available on this site.

10/20/1982 SUPPL-31 Efficacy

Label is not available on this site.

10/20/1978 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/29/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1978 SUPPL-27 Efficacy

Label is not available on this site.

10/17/1978 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1978 SUPPL-25 Labeling

Label is not available on this site.

05/05/1976 SUPPL-24 Labeling

Label is not available on this site.

05/06/1976 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1975 SUPPL-13 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2017 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013295s070lbl.pdf
07/06/2015 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf

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