Renovist Ii

   
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Renovist Ii


Drug - Renovist Ii
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) - Diatrizoate Meglumine; Diatrizoate Sodium
Multiple ingredients are in alphabetical order.

Strength - 28.5%;29.1%
The potency of the active ingredient(s), Diatrizoate Meglumine; Diatrizoate Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 010040
The FDA assigned number to Renovist Ii. Format is nnnnnn.

Product Number - 019
The FDA assigned number to identify Renovist Ii. 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 Renovist Ii 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 Renovist Ii. 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 Renovist Ii 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 Renovist Ii.

Renovist Ii