Chenix

   
Google
 
Web NewDrugInformation.com

Chenix


Drug - Chenix
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) - Chenodiol
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 018513
The FDA assigned number to Chenix. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Chenix. 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 - Jul 28, 1983
The date Chenix 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 Chenix. 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 Chenix 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 Chenix.

Chenix