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Klaron Drug - Klaron The trade name of the product as shown on the labeling. Dosage - LOTION; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Sulfacetamide Sodium Multiple ingredients are in alphabetical order. Strength - 10% The potency of the active ingredient(s), Sulfacetamide Sodium. May repeat for multiple part products. Applicant - DERMIK LABS The firm name holding legal responsibility for Klaron. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 019931 The FDA assigned number to Klaron. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Klaron. 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, 1996 The date Klaron 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 Klaron. 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 Klaron is in. Format is RX, OTC, DISCN. Applicant Full Name - Dermik Laboratories Div Aventis Pharmaceuticals Inc The full name of the firm holding legal responsibility for the new application of Klaron. Klaron Carafate 1gm Tablet; Oral Sucralfate 1gm Tablet; Oral Sucralfate 1gm Tablet; Oral Sufenta Eq 0.05mg Base/ml Injectable; Injection Sufentanil Citrate Eq 0.05mg Base/ml Injectable; Injection Sufentanil Citrate Eq 0.05mg Base/ml Injectable; Injection Sulfentanil Citrate Eq 0.05mg Base/ml Injectable; Injection Exelderm 1% Cream; Topical Exelderm 1% Solution; Topical Klaron 10% Lotion; Topical NewDrugInformation