Brethaire

   
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Brethaire


Drug - Brethaire
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) - Terbutaline Sulfate
Multiple ingredients are in alphabetical order.

Strength - 0.2MG/INH
The potency of the active ingredient(s), Terbutaline Sulfate. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Brethaire. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018762
The FDA assigned number to Brethaire. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Brethaire. 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 17, 1984
The date Brethaire 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 Brethaire. 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 Brethaire is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Brethaire.

Brethaire