Monurol

   
Google
 
Web NewDrugInformation.com

Monurol


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

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

Active Ingredient(s) - Fosfomycin Tromethamine
Multiple ingredients are in alphabetical order.

Strength - EQ 3GM BASE/PACKET
The potency of the active ingredient(s), Fosfomycin Tromethamine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050717
The FDA assigned number to Monurol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Monurol. 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 19, 1996
The date Monurol 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 Monurol. 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 Monurol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Zambon Corp
The full name of the firm holding legal responsibility for the new application of Monurol.

Monurol