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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215382

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NDA 215382 describes IOPAMIDOL, which is a drug marketed by Baxter Hlthcare, Hainan Poly, Hospira, Cook Imaging, Fresenius Kabi Usa, and Abbvie, and is included in eleven NDAs. It is available from two suppliers. Additional details are available on the IOPAMIDOL profile page.

The generic ingredient in IOPAMIDOL is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

Summary for 215382

Tradename:	IOPAMIDOL
Applicant:	Hainan Poly
Ingredient:	iopamidol
Patents:	0

Pharmacology for NDA: 215382

Mechanism of Action	X-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 215382

Contrast Media

Suppliers and Packaging for NDA: 215382

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124	70436-124-33	10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33)
IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124	70436-124-35	20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	41%
Approval Date:	Feb 27, 2023	TE:	AP1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	61%
Approval Date:	Feb 27, 2023	TE:	AP	RLD:	No

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