Avelox In Sodium Chloride 0.8% In Plastic Container

   
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Avelox In Sodium Chloride 0.8% In Plastic Container


Drug - Avelox In Sodium Chloride 0.8% In Plastic Container
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; IV (INFUSION)
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Moxifloxacin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 160MG/100ML
The potency of the active ingredient(s), Moxifloxacin Hydrochloride. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Avelox In Sodium Chloride 0.8% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021277
The FDA assigned number to Avelox In Sodium Chloride 0.8% In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Avelox In Sodium Chloride 0.8% 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 - Nov 30, 2001
The date Avelox In Sodium Chloride 0.8% 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 Avelox In Sodium Chloride 0.8% 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 Avelox In Sodium Chloride 0.8% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Avelox In Sodium Chloride 0.8% In Plastic Container.

Avelox In Sodium Chloride 0.8% In Plastic Container