Aredia

   
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Aredia


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - 60MG/VIAL
The potency of the active ingredient(s), Pamidronate Disodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020036
The FDA assigned number to Aredia. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Aredia. 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 - May 6, 1993
The date Aredia 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 Aredia. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Aredia 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 Aredia.

Aredia