Omnipaque 300

   
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Omnipaque 300


Drug - Omnipaque 300
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; INJECTION, ORAL, RECTAL
The product dosage form and route separated by a semi-colon.

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

Strength - 64.7%
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 300. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020608
The FDA assigned number to Omnipaque 300. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Omnipaque 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 - Oct 24, 1995
The date Omnipaque 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) - No
The pioneer or innovator of Omnipaque 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 Omnipaque 300 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 300.

Omnipaque 300