Ventolin

   
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Ventolin


Drug - Ventolin
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Albuterol Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 2MG BASE
The potency of the active ingredient(s), Albuterol Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019112
The FDA assigned number to Ventolin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ventolin. 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 - Jul 10, 1986
The date Ventolin 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 Ventolin. 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 Ventolin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Ventolin.

Ventolin