Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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 DRAXIMAGE
SODIUM IODIDE I 131 SODIUM IODIDE I-131 250-1000mCi SOLUTION;ORAL Prescription No AA 209166 INTL ISOTOPES

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English