Angiovist 292

   
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Angiovist 292


Drug - Angiovist 292
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 Meglumine; Diatrizoate Sodium
Multiple ingredients are in alphabetical order.

Strength - 52%;8%
The potency of the active ingredient(s), Diatrizoate Meglumine; Diatrizoate Sodium. May repeat for multiple part products.

Applicant - BERLEX
The firm name holding legal responsibility for Angiovist 292. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087724
The FDA assigned number to Angiovist 292. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Angiovist 292. 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 - Sep 23, 1982
The date Angiovist 292 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 Angiovist 292. 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 Angiovist 292 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Berlex Inc
The full name of the firm holding legal responsibility for the new application of Angiovist 292.

Angiovist 292