Omnipaque 70

   
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Omnipaque 70


Drug - Omnipaque 70
The trade name of the product as shown on the labeling.

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

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

Strength - 15.1%
The potency of the active ingredient(s), Iohexol. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Omnipaque 70. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018956
The FDA assigned number to Omnipaque 70. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Omnipaque 70. 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 - Jun 1, 1994
The date Omnipaque 70 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 Omnipaque 70. 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 Omnipaque 70 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ge Healthcare
The full name of the firm holding legal responsibility for the new application of Omnipaque 70.

Omnipaque 70