Ultravist 300

   
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Ultravist 300


Drug - Ultravist 300
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) - Iopromide
Multiple ingredients are in alphabetical order.

Strength - 62.3%
The potency of the active ingredient(s), Iopromide. May repeat for multiple part products.

Applicant - BERLEX
The firm name holding legal responsibility for Ultravist 300. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020220
The FDA assigned number to Ultravist 300. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ultravist 300. 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 - May 10, 1995
The date Ultravist 300 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 Ultravist 300. 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 Ultravist 300 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Berlex Inc
The full name of the firm holding legal responsibility for the new application of Ultravist 300.

Ultravist 300