Demadex
Drug - Demadex
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) -
Torsemide
Multiple ingredients are in alphabetical order.
Strength -
10MG
The potency of the active ingredient(s), Torsemide. May repeat for multiple part products.
Applicant -
ROCHE
The firm name holding legal responsibility for Demadex. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020136
The FDA assigned number to Demadex. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Demadex. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Aug 23, 1993
The date Demadex 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 Demadex. 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 Demadex is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Demadex.
Demadex
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