Unithroid

   
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Unithroid


Drug - Unithroid
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) - Levothyroxine Sodium
Multiple ingredients are in alphabetical order.

Strength - 0.025MG **See Current Cumulative Supplement 1.3
The potency of the active ingredient(s), Levothyroxine Sodium. May repeat for multiple part products.

Applicant - STEVENS J
The firm name holding legal responsibility for Unithroid. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021210
The FDA assigned number to Unithroid. Format is nnnnnn.

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

Therapeutic Equivalence (TE) Code - AB1,AB2,AB3
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 21, 2000
The date Unithroid 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) - No
The pioneer or innovator of Unithroid. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Jerome Stevens Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Unithroid.

Unithroid