Details for New Drug Application (NDA): 214271
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NDA 214271 describes IODIXANOL, which is a drug marketed by Hengrui Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the IODIXANOL profile page.
The generic ingredient in IODIXANOL is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.
The generic ingredient in IODIXANOL is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.
Summary for 214271
| Tradename: | IODIXANOL |
| Applicant: | Hengrui Pharma |
| Ingredient: | iodixanol |
| Patents: | 0 |
Pharmacology for NDA: 214271
| Mechanism of Action | X-Ray Contrast Activity |
Suppliers and Packaging for NDA: 214271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IODIXANOL | iodixanol | INJECTABLE;INJECTION | 214271 | ANDA | FRESENIUS KABI USA, LLC | 65219-381 | 65219-381-10 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03) |
| IODIXANOL | iodixanol | INJECTABLE;INJECTION | 214271 | ANDA | FRESENIUS KABI USA, LLC | 65219-381 | 65219-381-50 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 55% | ||||
| Approval Date: | May 19, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 65.2% | ||||
| Approval Date: | May 19, 2022 | TE: | AP | RLD: | No | ||||
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