Uroplus Ss

   
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Uroplus Ss


Drug - Uroplus Ss
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) - Sulfamethoxazole; Trimethoprim
Multiple ingredients are in alphabetical order.

Strength - 400MG;80MG
The potency of the active ingredient(s), Sulfamethoxazole; Trimethoprim. May repeat for multiple part products.

Applicant - SHIONOGI
The firm name holding legal responsibility for Uroplus Ss. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071815
The FDA assigned number to Uroplus Ss. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Uroplus Ss. 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 - Sep 28, 1987
The date Uroplus Ss 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 Uroplus Ss. 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 Uroplus Ss is in. Format is RX, OTC, DISCN.

Applicant Full Name - Shionogi Usa Inc
The full name of the firm holding legal responsibility for the new application of Uroplus Ss.

Uroplus Ss