Zometa

   
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Zometa


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

Dosage - INJECTABLE; IV (INFUSION)
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 4MG BASE/5ML
The potency of the active ingredient(s), Zoledronic Acid. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021223
The FDA assigned number to Zometa. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Zometa. 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 - Mar 7, 2003
The date Zometa 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 Zometa. 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 Zometa is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Zometa.

Zometa