Ultravist (pharmacy Bulk)

   
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Ultravist (pharmacy Bulk)


Drug - Ultravist (pharmacy Bulk)
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 - 76.9%
The potency of the active ingredient(s), Iopromide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021425
The FDA assigned number to Ultravist (pharmacy Bulk). Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ultravist (pharmacy Bulk). 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 - Sep 20, 2002
The date Ultravist (pharmacy Bulk) 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 (pharmacy Bulk). 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 (pharmacy Bulk) 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 (pharmacy Bulk).

Ultravist (pharmacy Bulk)