Triple Sulfa

   
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Triple Sulfa


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

Dosage - CREAM; VAGINAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Triple Sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)
Multiple ingredients are in alphabetical order.

Strength - 3.7%;2.86%;3.42%
The potency of the active ingredient(s), Triple Sulfa (sulfabenzamide;sulfacetamide;sulfathiazole). May repeat for multiple part products.

Applicant - FOUGERA
The firm name holding legal responsibility for Triple Sulfa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086424
The FDA assigned number to Triple Sulfa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Triple Sulfa. 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 - Approved Prior to Jan 1, 1982
The date Triple Sulfa 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 Triple Sulfa. 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 Triple Sulfa is in. Format is RX, OTC, DISCN.

Applicant Full Name - E Fougera Div Altana Inc
The full name of the firm holding legal responsibility for the new application of Triple Sulfa.

Triple Sulfa