Endosol Extra

   
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Endosol Extra


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

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

Active Ingredient(s) - Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate
Multiple ingredients are in alphabetical order.

Strength - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
The potency of the active ingredient(s), Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate. May repeat for multiple part products.

Applicant - AKORN
The firm name holding legal responsibility for Endosol Extra. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020079
The FDA assigned number to Endosol Extra. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Endosol Extra. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 27, 1991
The date Endosol Extra 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 Endosol Extra. 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 Endosol Extra is in. Format is RX, OTC, DISCN.

Applicant Full Name - Akorn Inc
The full name of the firm holding legal responsibility for the new application of Endosol Extra.

Endosol Extra