Web NewDrugInformation.com

Haloperidol Intensol Drug - Haloperidol Intensol The trade name of the product as shown on the labeling. Dosage - CONCENTRATE; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Haloperidol Lactate Multiple ingredients are in alphabetical order. Strength - EQ 2MG BASE/ML The potency of the active ingredient(s), Haloperidol Lactate. May repeat for multiple part products. Applicant - ROXANE The firm name holding legal responsibility for Haloperidol Intensol. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 072045 The FDA assigned number to Haloperidol Intensol. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Haloperidol Intensol. 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 - Apr 12, 1988 The date Haloperidol Intensol 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 Haloperidol Intensol. 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 Haloperidol Intensol is in. Format is RX, OTC, DISCN. Applicant Full Name - Roxane Laboratories Inc The full name of the firm holding legal responsibility for the new application of Haloperidol Intensol. Haloperidol Intensol Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral Haloperidol Intensol Eq 2mg Base/ml Concentrate; Oral Haloperidol Decanoate Eq 50mg Base/ml Injectable; Injection Haldol Eq 2mg Base/ml Concentrate; Oral Haloperidol Eq 2mg Base/ml Concentrate; Oral NewDrugInformation