Optiray 300

   
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Optiray 300


Drug - Optiray 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) - Ioversol
Multiple ingredients are in alphabetical order.

Strength - 64%
The potency of the active ingredient(s), Ioversol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019710
The FDA assigned number to Optiray 300. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Optiray 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 - Jan 22, 1992
The date Optiray 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 Optiray 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 Optiray 300 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Medical Inc
The full name of the firm holding legal responsibility for the new application of Optiray 300.

Optiray 300