Ventolin Hfa

   
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Ventolin Hfa


Drug - Ventolin Hfa
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) - Albuterol Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.09MG BASE/INH
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 Hfa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020983
The FDA assigned number to Ventolin Hfa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ventolin Hfa. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BX
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Apr 19, 2001
The date Ventolin Hfa 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 Ventolin Hfa. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Ventolin Hfa 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 Hfa.

Ventolin Hfa