Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215382
Company: HAINAN POLY

Products on ANDA 215382

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IOPAMIDOL	IOPAMIDOL	41%	INJECTABLE;INJECTION	Prescription	AP1	No	No
IOPAMIDOL	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215382

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215382

IOPAMIDOL

INJECTABLE;INJECTION; 41%
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IOPAMIDOL	IOPAMIDOL	41%	INJECTABLE;INJECTION	Prescription	No	AP1	215382	HAINAN POLY
ISOVUE-M 200	IOPAMIDOL	41%	INJECTABLE;INJECTION	Prescription	Yes	AP1	018735	BRACCO

INJECTABLE;INJECTION; 61%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IOPAMIDOL	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	No	AP	215382	HAINAN POLY
IOPAMIDOL	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	No	AP	217134	HAINAN POLY
ISOVUE-300	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	Yes	AP	018735	BRACCO
ISOVUE-M 300	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	Yes	AP	018735	BRACCO