Xopenex Hfa

   
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Xopenex Hfa


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

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

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

Strength - EQ 0.045MG BASE/INH
The potency of the active ingredient(s), Levalbuterol Tartrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021730
The FDA assigned number to Xopenex Hfa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Xopenex Hfa. 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 11, 2005
The date Xopenex Hfa 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 Hfa. 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 Hfa is in. Format is RX, OTC, DISCN.

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

Xopenex Hfa