Pytest Kit

   
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Pytest Kit


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

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

Active Ingredient(s) - Urea, C-14
Multiple ingredients are in alphabetical order.

Strength - 1uCi
The potency of the active ingredient(s), Urea, C-14. May repeat for multiple part products.

Applicant - BALLARD MEDCL
The firm name holding legal responsibility for Pytest Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020617
The FDA assigned number to Pytest Kit. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pytest Kit. 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 - May 9, 1997
The date Pytest Kit 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 Pytest Kit. 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 Pytest Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ballard Medical Products Inc
The full name of the firm holding legal responsibility for the new application of Pytest Kit.

Pytest Kit