Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214201
Company: ANDA REPOSITORY

Products on ANDA 214201

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214201

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

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