Osmovist 190

   
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Osmovist 190


Drug - Osmovist 190
The trade name of the product as shown on the labeling.

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

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

Strength - 40.6%
The potency of the active ingredient(s), Iotrolan. May repeat for multiple part products.

Applicant - BERLEX
The firm name holding legal responsibility for Osmovist 190. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019580
The FDA assigned number to Osmovist 190. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Osmovist 190. 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 - Dec 7, 1989
The date Osmovist 190 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 Osmovist 190. 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 Osmovist 190 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 Osmovist 190.

Osmovist 190