Fluconazole In Sodium Chloride 0.9%

   
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Fluconazole In Sodium Chloride 0.9%


Drug - Fluconazole In Sodium Chloride 0.9%
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) - Fluconazole
Multiple ingredients are in alphabetical order.

Strength - 200MG/100ML
The potency of the active ingredient(s), Fluconazole. May repeat for multiple part products.

Applicant - BEDFORD
The firm name holding legal responsibility for Fluconazole In Sodium Chloride 0.9%. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076087
The FDA assigned number to Fluconazole In Sodium Chloride 0.9%. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fluconazole In Sodium Chloride 0.9%. 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 - Jul 29, 2004
The date Fluconazole In Sodium Chloride 0.9% 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 Fluconazole In Sodium Chloride 0.9%. 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 Fluconazole In Sodium Chloride 0.9% is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bedford Laboratories Div Ben Venue Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Fluconazole In Sodium Chloride 0.9%.

Fluconazole In Sodium Chloride 0.9%