Roxicet

   
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Roxicet


Drug - Roxicet
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 - 325MG;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. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087003
The FDA assigned number to Roxicet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Roxicet. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Roxicet 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 Roxicet. 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 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.

Roxicet