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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216125
Company: BAMF

Products on ANDA 216125

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-400mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216125

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216125

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 20-400mCi/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	20-400mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216125	BAMF
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-400mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021870	FEINSTEIN

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