Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202586
Company: BWXT ITG

Products on ANDA 202586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202586Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202586

INDIUM IN 111 OXYQUINOLINE

INJECTABLE;INJECTION; 1mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	No	AP	202586	BWXT ITG
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019044	GE HEALTHCARE