Idkit:hp

   
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Idkit:hp


Drug - Idkit:hp
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Citric Acid; Urea, C-13
Multiple ingredients are in alphabetical order.

Strength - N/A,4GM;75MG,N/A
The potency of the active ingredient(s), Citric Acid; Urea, C-13. May repeat for multiple part products.

Applicant - ORIDION
The firm name holding legal responsibility for Idkit:hp. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021314
The FDA assigned number to Idkit:hp. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Idkit:hp. 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 - Dec 17, 2002
The date Idkit:hp 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 Idkit:hp. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Oridion Breathid Inc
The full name of the firm holding legal responsibility for the new application of Idkit:hp.

Idkit:hp