Arduan
Drug - Arduan
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) -
Pipecuronium Bromide
Multiple ingredients are in alphabetical order.
Strength -
10MG/VIAL
The potency of the active ingredient(s), Pipecuronium Bromide. May repeat for multiple part products.
Applicant -
ORGANON USA INC
The firm name holding legal responsibility for Arduan. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019638
The FDA assigned number to Arduan. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Arduan. 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 -
Jun 26, 1990
The date Arduan 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 Arduan. 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 Arduan is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Organon Usa Inc
The full name of the firm holding legal responsibility for the new application of Arduan.
Arduan
|
