Isopaque 440

   
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Isopaque 440


Drug - Isopaque 440
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) - Calcium Metrizoate; Meglumine Metrizoate; Metrizoate Magnesium; Metrizoate Sodium
Multiple ingredients are in alphabetical order.

Strength - 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML
The potency of the active ingredient(s), Calcium Metrizoate; Meglumine Metrizoate; Metrizoate Magnesium; Metrizoate Sodium. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Isopaque 440. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016847
The FDA assigned number to Isopaque 440. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Isopaque 440. 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 Isopaque 440 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 Isopaque 440. 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 Isopaque 440 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 Isopaque 440.

Isopaque 440


Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation
Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation
Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation
Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation
Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation
Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection
Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection
Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection
Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection
Isopaque 440 0.78mg/ml;75.9mg/ml;0.15mg/ml;16.6mg/ml Injectable; Injection

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