Darvocet A500

   
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Darvocet A500


Drug - Darvocet A500
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; Propoxyphene Napsylate
Multiple ingredients are in alphabetical order.

Strength - 500MG;100MG
The potency of the active ingredient(s), Acetaminophen; Propoxyphene Napsylate. May repeat for multiple part products.

Applicant - XANODYNE PHARM
The firm name holding legal responsibility for Darvocet A500. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076429
The FDA assigned number to Darvocet A500. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Darvocet A500. 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 10, 2003
The date Darvocet A500 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 Darvocet A500. 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 Darvocet A500 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Xanodyne Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Darvocet A500.

Darvocet A500