Resectisol

   
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Resectisol


Drug - Resectisol
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) - Mannitol
Multiple ingredients are in alphabetical order.

Strength - 5GM/100ML
The potency of the active ingredient(s), Mannitol. May repeat for multiple part products.

Applicant - B BRAUN
The firm name holding legal responsibility for Resectisol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016704
The FDA assigned number to Resectisol. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Resectisol. 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 - Approved Prior to Jan 1, 1982
The date Resectisol 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 Resectisol. 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 Resectisol is in. Format is RX, OTC, DISCN.

Applicant Full Name - B Braun Medical Inc
The full name of the firm holding legal responsibility for the new application of Resectisol.

Resectisol