Percodan-demi

   
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Percodan-demi


Drug - Percodan-demi
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;2.25MG;0.19MG
The potency of the active ingredient(s), Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate. May repeat for multiple part products.

Applicant - ENDO PHARMS
The firm name holding legal responsibility for Percodan-demi. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 007337
The FDA assigned number to Percodan-demi. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Percodan-demi. 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 Percodan-demi 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 Percodan-demi. 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 Percodan-demi is in. Format is RX, OTC, DISCN.

Applicant Full Name - Endo Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Percodan-demi.

Percodan-demi