An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203811
Company: UCLA BIOMEDICAL

Products on ANDA 203811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	4-40mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203811

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 4-40mCi/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	4-40mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204759	KETTERING MEDCTR
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	4-40mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203811	UCLA BIOMEDICAL

Top