Duraclon

   
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Duraclon


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - 0.5MG/ML
The potency of the active ingredient(s), Clonidine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020615
The FDA assigned number to Duraclon. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Duraclon. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Apr 27, 1999
The date Duraclon 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 Duraclon. 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 Duraclon 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 Duraclon.

Duraclon