Details for New Drug Application (NDA): 203603
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NDA 203603 describes FLUDEOXYGLUCOSE F18, which is a drug marketed by Downstate Clincl, 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Decatur, Essential Isotopes, Feinstein, Hot Shots Nm Llc, Isologic Innovative, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Northland, Nukemed, Petnet, Pharmalogic, Pharmalogic Hldgs, Precision Nuclear, Queen Hamamatsu Pet, Sofie, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ Southern Ca, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Utah Cyclotron, Weill Medcl Coll, Wisconsin, and Wusm Cyclotron, and is included in forty-three NDAs. It is available from twenty-six suppliers. Additional details are available on the FLUDEOXYGLUCOSE F18 profile page.
The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.
The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.
Summary for 203603
| Tradename: | FLUDEOXYGLUCOSE F18 |
| Applicant: | Cardinal Health 414 |
| Ingredient: | fludeoxyglucose f-18 |
| Patents: | 0 |
Pharmacology for NDA: 203603
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 203603 | ANDA | Cardinal Health 414, LLC | 65857-150 | 65857-150-30 | 30 mL in 1 VIAL, GLASS (65857-150-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-300mCi/ML | ||||
| Approval Date: | Nov 13, 2015 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-500mCi/ML | ||||
| Approval Date: | Sep 27, 2018 | TE: | AP | RLD: | No | ||||
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