Rubratope-57

   
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Rubratope-57


Drug - Rubratope-57
The trade name of the product as shown on the labeling.

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cyanocobalamin, Co-57
Multiple ingredients are in alphabetical order.

Strength - 0.5-1uCi
The potency of the active ingredient(s), Cyanocobalamin, Co-57. May repeat for multiple part products.

Applicant - BRACCO
The firm name holding legal responsibility for Rubratope-57. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016089
The FDA assigned number to Rubratope-57. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Rubratope-57. 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 Rubratope-57 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 Rubratope-57. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Rubratope-57 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bracco Diagnostics Inc
The full name of the firm holding legal responsibility for the new application of Rubratope-57.

Rubratope-57