Hexabrix

   
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Hexabrix


Drug - Hexabrix
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) - Ioxaglate Meglumine; Ioxaglate Sodium
Multiple ingredients are in alphabetical order.

Strength - 39.3%;19.6%
The potency of the active ingredient(s), Ioxaglate Meglumine; Ioxaglate Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018905
The FDA assigned number to Hexabrix. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Hexabrix. 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 - Jul 26, 1985
The date Hexabrix 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 Hexabrix. 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 Hexabrix is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Medical Inc
The full name of the firm holding legal responsibility for the new application of Hexabrix.

Hexabrix