Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209341
Company: UNIV SOUTHERN CA
Company: UNIV SOUTHERN CA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/16/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUDEOXYGLUCOSE F18
INJECTABLE;INTRAVENOUS; 20-300mCi/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203778 | 3D IMAGING DRUG |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203710 | BIOMEDCL RES FDN |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203837 | BIOMEDCL RES FDN |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203816 | BRIGHAM WOMENS |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203603 | CARDINAL HEALTH 414 |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204385 | CHILDRENS HOSP MI |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204525 | CPDC |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204463 | DECATUR |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203946 | ESSENTIAL ISOTOPES |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203920 | JUBILANT DRAXIMAGE |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204333 | MA GENERAL HOSP |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208679 | MEM SLOAN-KETTERING |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203904 | METHODIST HOSP RES |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204472 | MIPS CRF |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204512 | NCM USA BRONX LLC |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204264 | SHERTECH LABS LLC |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203591 | SOFIE |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203902 | UCSF RODIOPHARM |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203990 | UIHC PET IMAGING |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204531 | UNIV MICHIGAN |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209341 | UNIV SOUTHERN CA |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203246 | UNIV TX MD ANDERSON |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204498 | UNIV UTAH CYCLOTRON |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-300mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203935 | WUSM CYCLOTRON |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English