Broncho Saline

   
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Broncho Saline


Drug - Broncho Saline
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) - Sodium Chloride
Multiple ingredients are in alphabetical order.

Strength - 0.9%
The potency of the active ingredient(s), Sodium Chloride. May repeat for multiple part products.

Applicant - BLAIREX
The firm name holding legal responsibility for Broncho Saline. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019912
The FDA assigned number to Broncho Saline. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Broncho Saline. 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 - Sep 3, 1992
The date Broncho Saline 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 Broncho Saline. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Blairex Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Broncho Saline.

Broncho Saline