Chibroxin

   
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Chibroxin


Drug - Chibroxin
The trade name of the product as shown on the labeling.

Dosage - SOLUTION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

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

Strength - 0.3%
The potency of the active ingredient(s), Norfloxacin. May repeat for multiple part products.

Applicant - MERCK
The firm name holding legal responsibility for Chibroxin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019757
The FDA assigned number to Chibroxin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Chibroxin. 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 - Jun 17, 1991
The date Chibroxin 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 Chibroxin. 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 Chibroxin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck Research Laboratories Div Merck Co Inc
The full name of the firm holding legal responsibility for the new application of Chibroxin.

Chibroxin