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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016983
Company: LIEBEL-FLARSHEIM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONRAY 30 IOTHALAMATE MEGLUMINE 30% 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
08/06/1971 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/05/2017 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016983s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf
07/06/2015 SUPPL-35 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
12/19/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
05/10/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
10/27/1999 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/13/1995 SUPPL-28 Labeling

Label is not available on this site.
08/28/1992 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/04/1992 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
03/30/1990 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
06/12/1989 SUPPL-24 Labeling

Label is not available on this site.
12/01/1989 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
10/10/1989 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/08/1985 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/09/1985 SUPPL-20 Efficacy

Label is not available on this site.
11/07/1984 SUPPL-19 Labeling

Label is not available on this site.
06/28/1989 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.
06/25/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
08/16/1982 SUPPL-15 Labeling

Label is not available on this site.
08/24/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
08/16/1982 SUPPL-13 Labeling

Label is not available on this site.
09/08/1976 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.
06/20/1977 SUPPL-9 Efficacy

Label is not available on this site.
05/05/1976 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.
01/23/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
07/30/1975 SUPPL-5 Manufacturing (CMC)-Control

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-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016983s037lbl.pdf
07/06/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf
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