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.
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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215382
| Mechanism of Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 215382
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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