Hypaque

   
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Hypaque


Drug - Hypaque
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) - Diatrizoate Sodium
Multiple ingredients are in alphabetical order.

Strength - 25%
The potency of the active ingredient(s), Diatrizoate Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 009561
The FDA assigned number to Hypaque. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Hypaque. 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 Hypaque 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 Hypaque. 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 Hypaque 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 Hypaque.

Hypaque