Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209166
Company: INTL ISOTOPES

Products on ANDA 209166

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM IODIDE I 131	SODIUM IODIDE I-131	250-1000mCi	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209166Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209166

SODIUM IODIDE I 131

SOLUTION;ORAL; 250-1000mCi
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HICON	SODIUM IODIDE I-131	250-1000mCi	SOLUTION;ORAL	Prescription	Yes	AA	021305	JUBILANT
SODIUM IODIDE I 131	SODIUM IODIDE I-131	250-1000mCi	SOLUTION;ORAL	Prescription	No	AA	209166	INTL ISOTOPES