Truvada
Drug - Truvada
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) -
Emtricitabine; Tenofovir Disoproxil Fumarate
Multiple ingredients are in alphabetical order.
Strength -
200MG;300MG
The potency of the active ingredient(s), Emtricitabine; Tenofovir Disoproxil Fumarate. May repeat for multiple part products.
Applicant -
GILEAD
The firm name holding legal responsibility for Truvada. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021752
The FDA assigned number to Truvada. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Truvada. 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 -
Aug 2, 2004
The date Truvada 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 Truvada. 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 Truvada is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gilead Sciences Inc
The full name of the firm holding legal responsibility for the new application of Truvada.
Truvada
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