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.
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 Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 217134
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: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 41% | ||||
| Approval Date: | Sep 27, 2023 | TE: | AP2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 51% | ||||
| Approval Date: | Apr 9, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 61% | ||||
| Approval Date: | Apr 9, 2024 | TE: | AP | RLD: | No | ||||
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