Asmanex Twisthaler

   
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Asmanex Twisthaler


Drug - Asmanex Twisthaler
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) - Mometasone Furoate
Multiple ingredients are in alphabetical order.

Strength - 0.22MG/INH
The potency of the active ingredient(s), Mometasone Furoate. May repeat for multiple part products.

Applicant - SCHERING
The firm name holding legal responsibility for Asmanex Twisthaler. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021067
The FDA assigned number to Asmanex Twisthaler. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Asmanex Twisthaler. 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 30, 2005
The date Asmanex Twisthaler 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 Asmanex Twisthaler. 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 Asmanex Twisthaler is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering
The full name of the firm holding legal responsibility for the new application of Asmanex Twisthaler.

Asmanex Twisthaler