Roxiprin

   
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Roxiprin


Drug - Roxiprin
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) - Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate
Multiple ingredients are in alphabetical order.

Strength - 325MG;4.5MG;0.38MG
The potency of the active ingredient(s), Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 087743
The FDA assigned number to Roxiprin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Roxiprin. 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 4, 1982
The date Roxiprin 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 Roxiprin. 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 Roxiprin 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 Roxiprin.

Roxiprin