Web NewDrugInformation.com

Marcaine Hcl Preservative Free Drug - Marcaine Hcl 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) - Bupivacaine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 0.5% The potency of the active ingredient(s), Bupivacaine Hydrochloride. May repeat for multiple part products. Applicant - HOSPIRA The firm name holding legal responsibility for Marcaine Hcl Preservative Free. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 016964 The FDA assigned number to Marcaine Hcl Preservative Free. Format is nnnnnn. Product Number - 005 The FDA assigned number to identify Marcaine Hcl 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 Marcaine Hcl 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 Marcaine Hcl 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 Marcaine Hcl Preservative Free is in. Format is RX, OTC, DISCN. Applicant Full Name - Hospira Inc The full name of the firm holding legal responsibility for the new application of Marcaine Hcl Preservative Free. Marcaine Hcl Preservative Free Marcaine Hcl Preservative Free 0.5% Injectable; Injection Bupivacaine Hcl Kit 0.075% Injectable; Injection Bupivacaine Hcl Kit 0.114% Injectable; Injection Bupivacaine Hcl Kit 0.23% Injectable; Injection Bupivacine Hcl Preservative Free 0.25% Injectable; Injection Bupivacine Hcl Preservative Free 0.5% Injectable; Injection Bupivacine Hcl Preservative Free 0.75% Injectable; Injection Marcaine Hcl 0.25% Injectable; Injection Marcaine Hcl 0.5% Injectable; Injection Marcaine Hcl Preservative Free 0.25% Injectable; Injection NewDrugInformation