Raplon

   
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Raplon


Drug - Raplon
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) - Rapacuronium Bromide
Multiple ingredients are in alphabetical order.

Strength - 100MG/VIAL
The potency of the active ingredient(s), Rapacuronium Bromide. May repeat for multiple part products.

Applicant - ORGANON USA INC
The firm name holding legal responsibility for Raplon. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020984
The FDA assigned number to Raplon. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Raplon. 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 - Aug 18, 1999
The date Raplon 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 Raplon. 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 Raplon 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 Raplon.

Raplon