Prohance Multipack

   
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Prohance Multipack


Drug - Prohance Multipack
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) - Gadoteridol
Multiple ingredients are in alphabetical order.

Strength - 279.3MG/ML
The potency of the active ingredient(s), Gadoteridol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021489
The FDA assigned number to Prohance Multipack. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prohance Multipack. 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 - Oct 9, 2003
The date Prohance Multipack 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 Prohance Multipack. 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 Prohance Multipack 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 Prohance Multipack.

Prohance Multipack