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SODIUM IODIDE I 131

ANDA

SODIUM IODIDE I-131 | A209166 | INTERNATIONAL ISOTOPES INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HICON(TE code: AA)

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

UNIV MISSOURI RESEARCH REACTOR CENTERSODIUM IODIDE I-131 SOLUTION

DMF 328542018

NORDION CANADA INCInactiveSODIUM IODIDE I-131

DMF 63721986

MDS NORDIONInactiveSODIUM IODIDE I-131

DMF 92291991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 17, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250-1000mCi

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Feb 5, 2020

No patent or exclusivity listings for this strength.