Zmax

   
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Zmax


Drug - Zmax
The trade name of the product as shown on the labeling.

Dosage - FOR SUSPENSION, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Azithromycin
Multiple ingredients are in alphabetical order.

Strength - EQ 2GM BASE/BOT
The potency of the active ingredient(s), Azithromycin. May repeat for multiple part products.

Applicant - PFIZER GLOBAL
The firm name holding legal responsibility for Zmax. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050797
The FDA assigned number to Zmax. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zmax. 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 - Jun 10, 2005
The date Zmax 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 Zmax. 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 Zmax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Global Research Development
The full name of the firm holding legal responsibility for the new application of Zmax.

Zmax