Ziac

   
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Ziac


Drug - Ziac
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) - Bisoprolol Fumarate; Hydrochlorothiazide
Multiple ingredients are in alphabetical order.

Strength - 5MG;6.25MG
The potency of the active ingredient(s), Bisoprolol Fumarate; Hydrochlorothiazide. May repeat for multiple part products.

Applicant - DURAMED PHARMS BARR
The firm name holding legal responsibility for Ziac. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020186
The FDA assigned number to Ziac. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ziac. 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 - Mar 26, 1993
The date Ziac 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 Ziac. 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 Ziac is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Ziac.

Ziac