Hyzaar

   
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Hyzaar


Drug - Hyzaar
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) - Hydrochlorothiazide; Losartan Potassium
Multiple ingredients are in alphabetical order.

Strength - 12.5MG;100MG
The potency of the active ingredient(s), Hydrochlorothiazide; Losartan Potassium. May repeat for multiple part products.

Applicant - MERCK
The firm name holding legal responsibility for Hyzaar. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020387
The FDA assigned number to Hyzaar. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Hyzaar. 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 - Oct 20, 2005
The date Hyzaar 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 Hyzaar. 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 Hyzaar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck And Co Inc
The full name of the firm holding legal responsibility for the new application of Hyzaar.

Hyzaar