Roxicodone

   
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Roxicodone


Drug - Roxicodone
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Oxycodone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 30MG
The potency of the active ingredient(s), Oxycodone Hydrochloride. May repeat for multiple part products.

Applicant - XANODYNE PHARM
The firm name holding legal responsibility for Roxicodone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021011
The FDA assigned number to Roxicodone. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Roxicodone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 31, 2000
The date Roxicodone 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 Roxicodone. 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 Roxicodone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Xanodyne Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Roxicodone.

Roxicodone