Regroton

   
Google
 
Web NewDrugInformation.com

Regroton


Drug - Regroton
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) - Chlorthalidone; Reserpine
Multiple ingredients are in alphabetical order.

Strength - 50MG;0.25MG
The potency of the active ingredient(s), Chlorthalidone; Reserpine. May repeat for multiple part products.

Applicant - AVENTIS PHARMS
The firm name holding legal responsibility for Regroton. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 015103
The FDA assigned number to Regroton. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Regroton. 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 - Approved Prior to Jan 1, 1982
The date Regroton 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 Regroton. 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 Regroton is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Regroton.

Regroton