Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079086
Company: PETNET

Products on ANDA 079086

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079086

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.

Therapeutic Equivalents for ANDA 079086

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