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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087388
Company: LIEBEL-FLARSHEIM

Products on ANDA 087388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MD-GASTROVIEW	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	SOLUTION;ORAL, RECTAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/1981	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2009	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/30/2009	SUPPL-16	Labeling		Label is not available on this site.
04/26/2007	SUPPL-14	Labeling		Label is not available on this site.
07/13/2004	SUPPL-12	Labeling		Label is not available on this site.
07/13/2004	SUPPL-11	Labeling		Label is not available on this site.
02/27/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/21/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/21/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087388

MD-GASTROVIEW

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

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