Proventil-hfa

   
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Proventil-hfa


Drug - Proventil-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 - 3M
The firm name holding legal responsibility for Proventil-hfa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020503
The FDA assigned number to Proventil-hfa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Proventil-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 - Aug 15, 1996
The date Proventil-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 Proventil-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 Proventil-hfa is in. Format is RX, OTC, DISCN.

Applicant Full Name - 3m Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Proventil-hfa.

Proventil-hfa