Teveten Hct

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Teveten Hct

Drug - Teveten 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) - Eprosartan Mesylate; Hydrochlorothiazide
Multiple ingredients are in alphabetical order.

Strength - 600MG;12.5MG
The potency of the active ingredient(s), Eprosartan Mesylate; Hydrochlorothiazide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021268
The FDA assigned number to Teveten Hct. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Teveten 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 - Nov 1, 2001
The date Teveten 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 Teveten 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 Teveten Hct is in. Format is RX, OTC, DISCN.

Applicant Full Name - Kos Life Sciences Inc
The full name of the firm holding legal responsibility for the new application of Teveten Hct.

Teveten Hct