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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 076350

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NDA 076350 describes THYROSAFE, which is a drug marketed by Recip and is included in one NDA. It is available from one supplier. Additional details are available on the THYROSAFE profile page.

The generic ingredient in THYROSAFE is potassium iodide. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium iodide profile page.
Summary for 076350
Tradename:THYROSAFE
Applicant:Recip
Ingredient:potassium iodide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076350
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THYROSAFE potassium iodide TABLET;ORAL 076350 ANDA Recipharm AB (publ) 66983-350 66983-350-20 160 BOX in 1 CARTON (66983-350-20) > 20 BLISTER PACK in 1 BOX > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength65MG
Approval Date:Sep 10, 2002TE:RLD:No

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