Dicopac Kit

   
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Dicopac Kit


Drug - Dicopac 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) - Cyanocobalamin; Cyanocobalamin, Co-57; Cyanocobalamin, Co-58
Multiple ingredients are in alphabetical order.

Strength - N/A;N/A;N/A
The potency of the active ingredient(s), Cyanocobalamin; Cyanocobalamin, Co-57; Cyanocobalamin, Co-58. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Dicopac Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017406
The FDA assigned number to Dicopac Kit. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dicopac 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 Dicopac 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 Dicopac Kit. 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 Dicopac Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ge Healthcare
The full name of the firm holding legal responsibility for the new application of Dicopac Kit.

Dicopac Kit