Oxycodone Hcl

   
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Oxycodone Hcl


Drug - Oxycodone Hcl
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Oxycodone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 80MG
The potency of the active ingredient(s), Oxycodone Hydrochloride. May repeat for multiple part products.

Applicant - IMPAX LABS
The firm name holding legal responsibility for Oxycodone Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076318
The FDA assigned number to Oxycodone Hcl. Format is nnnnnn.

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

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

Approval Date - Sep 27, 2004
The date Oxycodone Hcl 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 Oxycodone Hcl. 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 Oxycodone Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Impax Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Oxycodone Hcl.

Oxycodone Hcl