Details for New Drug Application (NDA): 217737
✉ Email this page to a colleague
NDA 217737 describes IOHEXOL, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the IOHEXOL profile page.
The generic ingredient in IOHEXOL is iohexol. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the iohexol profile page.
The generic ingredient in IOHEXOL is iohexol. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the iohexol profile page.
Pharmacology for NDA: 217737
| Mechanism of Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 217737
Suppliers and Packaging for NDA: 217737
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IOHEXOL | iohexol | SOLUTION;INJECTION, ORAL | 217737 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-2466 | 80830-2466-2 | 10 BOTTLE, PLASTIC in 1 CARTON (80830-2466-2) / 50 mL in 1 BOTTLE, PLASTIC (80830-2466-1) |
| IOHEXOL | iohexol | SOLUTION;INJECTION, ORAL | 217737 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-2467 | 80830-2467-2 | 10 BOTTLE, PLASTIC in 1 CARTON (80830-2467-2) / 75 mL in 1 BOTTLE, PLASTIC (80830-2467-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 64.7% | ||||
| Approval Date: | Nov 13, 2025 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 26, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL | Strength | 75.5% | ||||
| Approval Date: | Jun 25, 2026 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
