Angiovist 282

   
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Angiovist 282


Drug - Angiovist 282
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
Multiple ingredients are in alphabetical order.

Strength - 60%
The potency of the active ingredient(s), Diatrizoate Meglumine. May repeat for multiple part products.

Applicant - BERLEX
The firm name holding legal responsibility for Angiovist 282. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087726
The FDA assigned number to Angiovist 282. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Angiovist 282. 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 282 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 282. 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 282 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 282.

Angiovist 282