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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203592
Company: SOFIE

Products on ANDA 203592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203592

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203592Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203592

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS; 10-200mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203777	3D IMAGING DRUG
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216126	BAMF
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204351	BIOMEDCL RES FDN
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203780	CARDINAL HEALTH 414
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203968	JUBILANT DRAXIMAGE
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203936	KREITCHMAN PET CTR
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204440	MIDWEST MEDCL
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204517	MIPS CRF
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204513	NCM USA BRONX LLC
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203890	PETNET
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204542	PRECISION NUCLEAR
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203592	SOFIE
SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	10-200mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204497	UNIV UTAH CYCLOTRON

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