Niaspan

   
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Niaspan


Drug - Niaspan
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) - Niacin
Multiple ingredients are in alphabetical order.

Strength - 750MG
The potency of the active ingredient(s), Niacin. May repeat for multiple part products.

Applicant - KOS LIFE
The firm name holding legal responsibility for Niaspan. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020381
The FDA assigned number to Niaspan. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Niaspan. 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 - Jul 28, 1997
The date Niaspan 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 Niaspan. 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 Niaspan is in. Format is RX, OTC, DISCN.

Applicant Full Name - Kos Life Sciences Inc
The full name of the firm holding legal responsibility for the new application of Niaspan.

Niaspan