Darvon Compound-65

   
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Darvon Compound-65


Drug - Darvon Compound-65
The trade name of the product as shown on the labeling.

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Aspirin; Caffeine; Propoxyphene Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 389MG;32.4MG;65MG
The potency of the active ingredient(s), Aspirin; Caffeine; Propoxyphene Hydrochloride. May repeat for multiple part products.

Applicant - XANODYNE PHARM
The firm name holding legal responsibility for Darvon Compound-65. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 010996
The FDA assigned number to Darvon Compound-65. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Darvon Compound-65. 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 - Mar 8, 1983
The date Darvon Compound-65 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 Darvon Compound-65. 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 Darvon Compound-65 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 Darvon Compound-65.

Darvon Compound-65