Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011245
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GASTROGRAFIN DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% SOLUTION;ORAL, RECTAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/1958 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
08/29/2005 SUPPL-32 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011245s032ltr.pdf
12/15/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/05/1994 SUPPL-29 Labeling

Label is not available on this site.

05/19/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/05/1991 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/14/1983 SUPPL-23 Labeling

Label is not available on this site.

08/03/1983 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1983 SUPPL-21 Labeling

Label is not available on this site.

09/14/1983 SUPPL-20 Efficacy

Label is not available on this site.

09/13/1979 SUPPL-19 Labeling

Label is not available on this site.

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

Label is not available on this site.

02/27/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1976 SUPPL-12 Labeling

Label is not available on this site.

GASTROGRAFIN

SOLUTION;ORAL, RECTAL; 66%;10%
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GASTROGRAFIN DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% SOLUTION;ORAL, RECTAL Prescription Yes AA 011245 BRACCO
MD-GASTROVIEW DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% SOLUTION;ORAL, RECTAL Prescription No AA 087388 LIEBEL-FLARSHEIM

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