Iprivask
Drug - Iprivask
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; SUBCUTANEOUS
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Desirudin Recombinant
Multiple ingredients are in alphabetical order.
Strength -
15MG/VIAL
The potency of the active ingredient(s), Desirudin Recombinant. May repeat for multiple part products.
Applicant -
CANYON
The firm name holding legal responsibility for Iprivask. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021271
The FDA assigned number to Iprivask. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Iprivask. 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 -
Apr 4, 2003
The date Iprivask 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 Iprivask. 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 Iprivask is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Canyon Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Iprivask.
Iprivask
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