Thyrosafe

   
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Thyrosafe


Drug - Thyrosafe
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Potassium Iodide
Multiple ingredients are in alphabetical order.

Strength - 65MG
The potency of the active ingredient(s), Potassium Iodide. May repeat for multiple part products.

Applicant - R R REGISTRATIONS
The firm name holding legal responsibility for Thyrosafe. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076350
The FDA assigned number to Thyrosafe. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Thyrosafe. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 10, 2002
The date Thyrosafe was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Thyrosafe. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Thyrosafe is in. Format is RX, OTC, DISCN.

Applicant Full Name - R And R Registrations
The full name of the firm holding legal responsibility for the new application of Thyrosafe.

Thyrosafe