Bronkometer

   
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Bronkometer


Drug - Bronkometer
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) - Isoetharine Mesylate
Multiple ingredients are in alphabetical order.

Strength - 0.34MG/INH
The potency of the active ingredient(s), Isoetharine Mesylate. May repeat for multiple part products.

Applicant - SANOFI SYNTHELABO
The firm name holding legal responsibility for Bronkometer. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012339
The FDA assigned number to Bronkometer. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Bronkometer. 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 - Approved Prior to Jan 1, 1982
The date Bronkometer 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 Bronkometer. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Bronkometer is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Bronkometer.

Bronkometer