Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011324
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SINOGRAFIN DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE 52.7%;26.8% SOLUTION;INTRAUTERINE 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
08/22/1958 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
08/29/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/16/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/29/1994 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2002 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11324s28ltr.pdf
01/28/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/06/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/03/1983 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1983 SUPPL-22 Labeling

Label is not available on this site.

07/11/1979 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1979 SUPPL-20 Labeling

Label is not available on this site.

02/15/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1978 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/31/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1978 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.

09/25/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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