| Product Information |
|
| Registration Number |
DRP-12217
|
| Generic Name |
Iodine (As Iohexol)
|
| Brand Name |
Saphiodine
|
| Dosage Strength |
300 mg/mL
|
| Dosage Form |
Solution For Injection
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
lodinated X-Ray Contrast Media
|
| Packaging |
USP Type I colorless glass vial, with grey bromobutyl rubber stopper and blue aluminum flip-off seal x 50 mL and 100 mL (Box of 1’s)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
01 July 2022
|
| Expiry Date |
01 July 2027
|