Fareston
Drug - Fareston
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) -
Toremifene Citrate
Multiple ingredients are in alphabetical order.
Strength -
EQ 60MG BASE
The potency of the active ingredient(s), Toremifene Citrate. May repeat for multiple part products.
Applicant -
GTX INC
The firm name holding legal responsibility for Fareston. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020497
The FDA assigned number to Fareston. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Fareston. 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 29, 1997
The date Fareston 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 Fareston. 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 Fareston is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gtx Inc
The full name of the firm holding legal responsibility for the new application of Fareston.
Fareston
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