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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203942
Company: KREITCHMAN PET CTR

Products on ANDA 203942

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	10-100mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203942

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 10-100mCi/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	10-100mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203942	KREITCHMAN PET CTR
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	10-100mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203771	QUEEN HAMAMATSU PET

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