Rubratope-57 Kit
Drug - Rubratope-57 Kit
The trade name of the product as shown on the labeling.
Dosage -
N/A; N/A
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Cobalt Chloride, Co-57; Cyanocobalamin; Cyanocobalamin, Co-57; Intrinsic Factor
Multiple ingredients are in alphabetical order.
Strength -
N/A;N/A;N/A;N/A
The potency of the active ingredient(s), Cobalt Chloride, Co-57; Cyanocobalamin; Cyanocobalamin, Co-57; Intrinsic Factor. May repeat for multiple part products.
Applicant -
BRACCO
The firm name holding legal responsibility for Rubratope-57 Kit. 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 Kit. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Rubratope-57 Kit. 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 Kit 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 Kit. 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 Kit 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 Kit.
Rubratope-57 Kit
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