Omnipaque 350

   
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Omnipaque 350


Drug - Omnipaque 350
The trade name of the product as shown on the labeling.

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

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

Strength - 75.5%
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 350. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020608
The FDA assigned number to Omnipaque 350. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Omnipaque 350. 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 350 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 350. 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 350 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 350.

Omnipaque 350