Bronitin Mist

   
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Bronitin Mist


Drug - Bronitin Mist
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) - Epinephrine Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 0.3MG/INH
The potency of the active ingredient(s), Epinephrine Bitartrate. May repeat for multiple part products.

Applicant - WYETH CONS
The firm name holding legal responsibility for Bronitin Mist. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016126
The FDA assigned number to Bronitin Mist. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Bronitin Mist. 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 Bronitin Mist 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 Bronitin Mist. 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 Bronitin Mist is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Consumer Healthcare
The full name of the firm holding legal responsibility for the new application of Bronitin Mist.

Bronitin Mist