Percocet

   
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Percocet


Drug - Percocet
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;10MG
The potency of the active ingredient(s), Acetaminophen; Oxycodone Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 040434
The FDA assigned number to Percocet. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Percocet. 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 - Nov 23, 2001
The date Percocet 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 Percocet. 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 Percocet 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 Percocet.

Percocet