Maxzide

   
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Maxzide


Drug - Maxzide
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; Triamterene
Multiple ingredients are in alphabetical order.

Strength - 50MG;75MG
The potency of the active ingredient(s), Hydrochlorothiazide; Triamterene. May repeat for multiple part products.

Applicant - MYLAN BERTEK
The firm name holding legal responsibility for Maxzide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019129
The FDA assigned number to Maxzide. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Maxzide. 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 - Oct 22, 1984
The date Maxzide 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 Maxzide. 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 Maxzide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Bertek Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Maxzide.

Maxzide