Cysto-conray Ii

   
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Cysto-conray Ii


Drug - Cysto-conray Ii
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; INTRAVESICAL
The product dosage form and route separated by a semi-colon.

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

Strength - 17.2%
The potency of the active ingredient(s), Iothalamate Meglumine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 017057
The FDA assigned number to Cysto-conray Ii. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cysto-conray 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 Cysto-conray 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 Cysto-conray Ii. 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 Cysto-conray Ii 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 Cysto-conray Ii.

Cysto-conray Ii