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Sublimaze Preservative Free Drug - Sublimaze Preservative Free The trade name of the product as shown on the labeling. Dosage - INJECTABLE; INJECTION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Fentanyl Citrate Multiple ingredients are in alphabetical order. Strength - EQ 0.05MG BASE/ML The potency of the active ingredient(s), Fentanyl Citrate. May repeat for multiple part products. Applicant - AKORN MFG The firm name holding legal responsibility for Sublimaze Preservative Free. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 016619 The FDA assigned number to Sublimaze Preservative Free. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Sublimaze Preservative Free. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AP The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Approved Prior to Jan 1, 1982 The date Sublimaze Preservative Free 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 Sublimaze Preservative Free. 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 Sublimaze Preservative Free is in. Format is RX, OTC, DISCN. Applicant Full Name - Akorn Manufacturing Inc The full name of the firm holding legal responsibility for the new application of Sublimaze Preservative Free. Sublimaze Preservative Free Fentanyl Citrate Eq 0.05mg Base/ml Injectable; Injection Fentanyl Citrate Eq 0.05mg Base/ml Injectable; Injection Fentanyl Citrate Preservative Free Eq 0.05mg Base/ml Injectable; Injection Fentanyl Citrate Preservative Free Eq 0.05mg Base/ml Injectable; Injection Fentanyl Citrate Preservative Free Eq 0.05mg Base/ml Injectable; Injection Sublimaze Preservative Free Eq 0.05mg Base/ml Injectable; Injection Fentanyl 50ugm/hr Film, Extended Release; Transdermal Fentanyl 75ugm/hr Film, Extended Release; Transdermal Fentanyl Citrate Eq 0.05mg Base/ml Injectable; Injection Fentanyl Citrate Eq 0.05mg Base/ml Injectable; Injection NewDrugInformation