Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018664
Company: ANBEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IOSAT POTASSIUM IODIDE 130MG TABLET;ORAL Over-the-counter None Yes Yes
IOSAT POTASSIUM IODIDE 65MG TABLET;ORAL Over-the-counter None Yes 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
10/14/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/06/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/17/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/12/2011 SUPPL-13 Manufacturing (CMC)-New Strength

Label is not available on this site.

01/14/2005 SUPPL-7 Labeling

Label is not available on this site.

09/13/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

11/04/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

IOSAT

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 65MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IOSAT POTASSIUM IODIDE 65MG TABLET;ORAL Over-the-counter Yes 018664 ANBEX
THYROSAFE POTASSIUM IODIDE 65MG TABLET;ORAL Over-the-counter No 076350 RECIP

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 130MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IOSAT POTASSIUM IODIDE 130MG TABLET;ORAL Over-the-counter Yes 018664 ANBEX

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