Multihance

   
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Multihance


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

Dosage - INJECTABLE; INTRAVENOUS
The product dosage form and route separated by a semi-colon.

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

Strength - 5.29GM/10ML (529MG/ML)
The potency of the active ingredient(s), Gadobenate Dimeglumine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021357
The FDA assigned number to Multihance. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Multihance. 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 - Nov 23, 2004
The date Multihance 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 Multihance. 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 Multihance is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bracco Diagnostics Inc
The full name of the firm holding legal responsibility for the new application of Multihance.

Multihance