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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217134


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NDA 217134 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 217134
Tradename:IOPAMIDOL
Applicant:Hainan Poly
Ingredient:iopamidol
Patents:0
Pharmacology for NDA: 217134
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 217134
Contrast Media
Suppliers and Packaging for NDA: 217134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IOPAMIDOL iopamidol INJECTABLE;INJECTION 217134 ANDA Slate Run Pharmaceuticals, LLC 70436-125 70436-125-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-125-82) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-125-37)
IOPAMIDOL iopamidol INJECTABLE;INJECTION 217134 ANDA Slate Run Pharmaceuticals, LLC 70436-127 70436-127-52 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength41%
Approval Date:Sep 27, 2023TE:AP2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength51%
Approval Date:Apr 9, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength61%
Approval Date:Apr 9, 2024TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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