Details for New Drug Application (NDA): 204328
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The generic ingredient in SODIUM FLUORIDE F-18 is sodium fluoride f-18. There are one thousand four hundred and seventy-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.
Summary for 204328
Tradename: | SODIUM FLUORIDE F-18 |
Applicant: | The Feinstein Inst |
Ingredient: | sodium fluoride f-18 |
Patents: | 0 |
Pharmacology for NDA: 204328
Mechanism of Action | Radiopharmaceutical Activity |
Medical Subject Heading (MeSH) Categories for 204328
Suppliers and Packaging for NDA: 204328
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM FLUORIDE F-18 | sodium fluoride f-18 | INJECTABLE;INTRAVENOUS | 204328 | ANDA | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-542 | 13267-542-42 | 20 mL in 1 VIAL, GLASS (13267-542-42) |
SODIUM FLUORIDE F-18 | sodium fluoride f-18 | INJECTABLE;INTRAVENOUS | 204328 | ANDA | BAMF Health Inc. | 81759-002 | 81759-002-30 | 1 VIAL, GLASS in 1 CONTAINER (81759-002-30) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-600mCi/ML | ||||
Approval Date: | Nov 19, 2014 | TE: | RLD: | No |
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