Levaquin In Dextrose 5% In Plastic Container

   
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Levaquin In Dextrose 5% In Plastic Container


Drug - Levaquin In Dextrose 5% In Plastic Container
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) - Levofloxacin
Multiple ingredients are in alphabetical order.

Strength - EQ 750MG /150ML(5MG/ML)
The potency of the active ingredient(s), Levofloxacin. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Levaquin In Dextrose 5% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020635
The FDA assigned number to Levaquin In Dextrose 5% In Plastic Container. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Levaquin In Dextrose 5% In Plastic Container. 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 - Dec 20, 1996
The date Levaquin In Dextrose 5% In Plastic Container 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 Levaquin In Dextrose 5% In Plastic Container. 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 Levaquin In Dextrose 5% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Levaquin In Dextrose 5% In Plastic Container.

Levaquin In Dextrose 5% In Plastic Container