Urso 250

   
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Urso 250


Drug - Urso 250
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) - Ursodiol
Multiple ingredients are in alphabetical order.

Strength - 250MG
The potency of the active ingredient(s), Ursodiol. May repeat for multiple part products.

Applicant - AXCAN SCANDIPHARM
The firm name holding legal responsibility for Urso 250. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020675
The FDA assigned number to Urso 250. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Urso 250. 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 10, 1997
The date Urso 250 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 Urso 250. 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 Urso 250 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Axcan Scandipharm Inc
The full name of the firm holding legal responsibility for the new application of Urso 250.

Urso 250