Iopamidol
Drug - Iopamidol
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) -
Iopamidol
Multiple ingredients are in alphabetical order.
Strength -
41%
The potency of the active ingredient(s), Iopamidol. May repeat for multiple part products.
Applicant -
BAXTER HLTHCARE
The firm name holding legal responsibility for Iopamidol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074629
The FDA assigned number to Iopamidol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Iopamidol. 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 -
Nov 6, 1996
The date Iopamidol 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 Iopamidol. 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 Iopamidol is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Baxter Healthcare Corp Anesthesia And Critical Care
The full name of the firm holding legal responsibility for the new application of Iopamidol.
Iopamidol
Omnipaque 210 45.3% Injectable; Injection Omnipaque 350 75.5% Solution; Injection, Oral Omnipaque 350 75.5% Solution; Injection, Oral Omnipaque 180 38.8% Solution; Injection, Oral, Rectal Omnipaque 240 51.8% Solution; Injection, Oral, Rectal Omnipaque 240 51.8% Solution; Injection, Oral, Rectal Omnipaque 300 64.7% Solution; Injection, Oral, Rectal Omnipaque 300 64.7% Solution; Injection, Oral, Rectal Omnipaque 70 15.1% Solution; Urethral Iopamidol 41% Injectable; Injection
NewDrugInformation
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