Details for New Drug Application (NDA): 204542
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NDA 204542 describes SODIUM FLUORIDE F-18, which is a drug marketed by 3d Imaging Drug, Bamf, Biomedcl Res Fdn, Cardinal Health 414, Decatur, Essential Isotopes, Hot Shots Nm Llc, Jubilant Draximage, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, and Univ Utah Cyclotron, and is included in twenty-four NDAs. It is available from ten suppliers. Additional details are available on the SODIUM FLUORIDE F-18 profile page.
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.
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 204542
| Tradename: | SODIUM FLUORIDE F-18 |
| Applicant: | Precision Nuclear |
| Ingredient: | sodium fluoride f-18 |
| Patents: | 0 |
Pharmacology for NDA: 204542
| Mechanism of Action | Radiopharmaceutical Activity |
Medical Subject Heading (MeSH) Categories for 204542
Suppliers and Packaging for NDA: 204542
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM FLUORIDE F-18 | sodium fluoride f-18 | INJECTABLE;INTRAVENOUS | 204542 | ANDA | Precision Nuclear LLC | 52768-125 | 52768-125-30 | 30 mL in 1 VIAL, MULTI-DOSE (52768-125-30) |
| SODIUM FLUORIDE F-18 | sodium fluoride f-18 | INJECTABLE;INTRAVENOUS | 204542 | ANDA | Precision Nuclear LLC | 52768-125 | 52768-125-50 | 50 mL in 1 VIAL, MULTI-DOSE (52768-125-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 10-200mCi/ML | ||||
| Approval Date: | Feb 27, 2015 | TE: | AP | RLD: | No | ||||
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