Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011245
Company: BRACCO

Products on NDA 011245

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011245

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.

Therapeutic Equivalents for NDA 011245

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
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	SOLUTION;ORAL, RECTAL	Prescription	No	AA	214201	ANDA REPOSITORY
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	SOLUTION;ORAL, RECTAL	Prescription	No	AA	215049	ANNORA PHARMA
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