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Soriatane Drug - Soriatane The trade name of the product as shown on the labeling. Dosage - CAPSULE; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Acitretin Multiple ingredients are in alphabetical order. Strength - 10MG The potency of the active ingredient(s), Acitretin. May repeat for multiple part products. Applicant - CONNETICS The firm name holding legal responsibility for Soriatane. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 019821 The FDA assigned number to Soriatane. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Soriatane. 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 - Oct 28, 1996 The date Soriatane 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 Soriatane. 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 Soriatane is in. Format is RX, OTC, DISCN. Applicant Full Name - Connetics Corp The full name of the firm holding legal responsibility for the new application of Soriatane. Soriatane Mucomyst 10% Solution; Inhalation, Oral Mucomyst 20% Solution; Inhalation, Oral Mucosil-10 10% Solution; Inhalation, Oral Mucosil-20 20% Solution; Inhalation, Oral Mucomyst W/ Isoproterenol 10%;0.05% Solution; Inhalation Acylanid 0.1mg Tablet; Oral Soriatane 10mg Capsule; Oral Acetylcysteine 20% Solution; Inhalation, Oral Acetylcysteine 10% Solution; Inhalation, Oral Acetylcysteine 20% Solution; Inhalation, Oral NewDrugInformation