Details for New Drug Application (NDA): 017279
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NDA 017279 describes GLOFIL-125, which is a drug marketed by Isotex and is included in one NDA. It is available from one supplier. Additional details are available on the GLOFIL-125 profile page.
The generic ingredient in GLOFIL-125 is iothalamate sodium i-125. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate sodium i-125 profile page.
The generic ingredient in GLOFIL-125 is iothalamate sodium i-125. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate sodium i-125 profile page.
Summary for 017279
| Tradename: | GLOFIL-125 |
| Applicant: | Isotex |
| Ingredient: | iothalamate sodium i-125 |
| Patents: | 0 |
Pharmacology for NDA: 017279
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 017279
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLOFIL-125 | iothalamate sodium i-125 | INJECTABLE;INJECTION | 017279 | NDA | Iso-Tex Diagnostics, Inc. | 50914-7729 | 50914-7729-2 | 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250-300uCi/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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