Urovist Cysto Pediatric

   
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Urovist Cysto Pediatric


Drug - Urovist Cysto Pediatric
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; URETERAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Diatrizoate Meglumine
Multiple ingredients are in alphabetical order.

Strength - 30%
The potency of the active ingredient(s), Diatrizoate Meglumine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 087731
The FDA assigned number to Urovist Cysto Pediatric. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Urovist Cysto Pediatric. 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 Urovist Cysto Pediatric 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 Urovist Cysto Pediatric. 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 Urovist Cysto Pediatric 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 Urovist Cysto Pediatric.

Urovist Cysto Pediatric