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Aralen Phosphate W/ Primaquine Phosphate Drug - Aralen Phosphate W/ Primaquine Phosphate 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) - Chloroquine Phosphate; Primaquine Phosphate Multiple ingredients are in alphabetical order. Strength - EQ 300MG BASE;EQ 45MG BASE The potency of the active ingredient(s), Chloroquine Phosphate; Primaquine Phosphate. May repeat for multiple part products. Applicant - SANOFI SYNTHELABO The firm name holding legal responsibility for Aralen Phosphate W/ Primaquine Phosphate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 014860 The FDA assigned number to Aralen Phosphate W/ Primaquine Phosphate. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Aralen Phosphate W/ Primaquine Phosphate. 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 Aralen Phosphate W/ Primaquine Phosphate 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 Aralen Phosphate W/ Primaquine Phosphate. 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 Aralen Phosphate W/ Primaquine Phosphate is in. Format is RX, OTC, DISCN. Applicant Full Name - Sanofi Synthelabo Inc The full name of the firm holding legal responsibility for the new application of Aralen Phosphate W/ Primaquine Phosphate. Aralen Phosphate W/ Primaquine Phosphate Chloroquine Phosphate Eq 150mg Base Tablet; Oral Chloroquine Phosphate Eq 150mg Base Tablet; Oral Chloroquine Phosphate Eq 150mg Base Tablet; Oral Chloroquine Phosphate Eq 300mg Base Tablet; Oral Chloroquine Phosphate Eq 150mg Base Tablet; Oral Chloroquine Phosphate Eq 300mg Base Tablet; Oral Aralen Phosphate W/ Primaquine Phosphate Eq 300mg Base;eq 45mg Base Tablet; Oral Chloroquine Phosphate Eq 150mg Base Tablet; Oral Chloroquine Phosphate Eq 300mg Base Tablet; Oral Chloroquine Phosphate Eq 150mg Base Tablet; Oral NewDrugInformation