Refludan
Drug - Refludan
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) -
Lepirudin Recombinant
Multiple ingredients are in alphabetical order.
Strength -
50MG/VIAL
The potency of the active ingredient(s), Lepirudin Recombinant. May repeat for multiple part products.
Applicant -
BERLEX
The firm name holding legal responsibility for Refludan. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020807
The FDA assigned number to Refludan. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Refludan. 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 -
Mar 6, 1998
The date Refludan 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) -
Yes
The pioneer or innovator of Refludan. 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 Refludan 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 Refludan.
Refludan
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