Maxzide-25

   
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Maxzide-25


Drug - Maxzide-25
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 - 25MG;37.5MG
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-25. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019129
The FDA assigned number to Maxzide-25. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Maxzide-25. 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 - May 13, 1988
The date Maxzide-25 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 Maxzide-25. 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-25 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-25.

Maxzide-25