Xanax Xr

   
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Xanax Xr


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

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

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

Strength - 2MG
The potency of the active ingredient(s), Alprazolam. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Xanax Xr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021434
The FDA assigned number to Xanax Xr. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Xanax Xr. 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 - Jan 17, 2003
The date Xanax Xr 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 Xanax Xr. 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 Xanax Xr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn
The full name of the firm holding legal responsibility for the new application of Xanax Xr.

Xanax Xr