Diovan Hct

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Diovan Hct

Drug - Diovan Hct
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydrochlorothiazide; Valsartan
Multiple ingredients are in alphabetical order.

Strength - 12.5MG;80MG
The potency of the active ingredient(s), Hydrochlorothiazide; Valsartan. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Diovan Hct. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020818
The FDA assigned number to Diovan Hct. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Diovan Hct. 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 - Mar 6, 1998
The date Diovan Hct 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 Diovan Hct. 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 Diovan Hct is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Diovan Hct.

Diovan Hct