Roxicet 5/500

   
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Roxicet 5/500


Drug - Roxicet 5/500
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) - Acetaminophen; Oxycodone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 500MG;5MG
The potency of the active ingredient(s), Acetaminophen; Oxycodone Hydrochloride. May repeat for multiple part products.

Applicant - ROXANE
The firm name holding legal responsibility for Roxicet 5/500. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089775
The FDA assigned number to Roxicet 5/500. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Roxicet 5/500. 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 - Jan 12, 1989
The date Roxicet 5/500 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 Roxicet 5/500. 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 Roxicet 5/500 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Roxicet 5/500.

Roxicet 5/500