Xopenex

   
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Xopenex


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

Dosage - SOLUTION; INHALATION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.021% BASE
The potency of the active ingredient(s), Levalbuterol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020837
The FDA assigned number to Xopenex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Xopenex. 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 25, 1999
The date Xopenex 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 Xopenex. 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 Xopenex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sepracor Inc
The full name of the firm holding legal responsibility for the new application of Xopenex.

Xopenex