Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079086
Company: PETNET
Company: PETNET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/25/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079086s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2020 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/27/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
FLUDEOXYGLUCOSE F18
INJECTABLE;INTRAVENOUS; 20-200mCi/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 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 079086 | PETNET |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203664 | PHARMALOGIC HLDGS |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203801 | TRUSTEES UNIV PA |