Advair Diskus 500/50

   
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Advair Diskus 500/50


Drug - Advair Diskus 500/50
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Fluticasone Propionate; Salmeterol Xinafoate
Multiple ingredients are in alphabetical order.

Strength - 0.5MG/INH;EQ 0.05MG BASE/INH
The potency of the active ingredient(s), Fluticasone Propionate; Salmeterol Xinafoate. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Advair Diskus 500/50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021077
The FDA assigned number to Advair Diskus 500/50. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Advair Diskus 500/50. 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 - Aug 24, 2000
The date Advair Diskus 500/50 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 Advair Diskus 500/50. 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 Advair Diskus 500/50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Advair Diskus 500/50.

Advair Diskus 500/50