Volmax

   
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Volmax


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

Dosage - TABLET, EXTENDED RELEASE; 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 8MG BASE
The potency of the active ingredient(s), Albuterol Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019604
The FDA assigned number to Volmax. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Volmax. 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 - Dec 23, 1992
The date Volmax 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 Volmax. 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 Volmax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Muro Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Volmax.

Volmax