Niaspan Titration Starter Pack

   
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Niaspan Titration Starter Pack


Drug - Niaspan Titration Starter Pack
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 - 375MG;500MG;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 Titration Starter Pack. The firm name is condensed to a maximum twenty character unique string.

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

Product Number - 005
The FDA assigned number to identify Niaspan Titration Starter Pack. 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 - Jul 28, 1997
The date Niaspan Titration Starter Pack 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 Niaspan Titration Starter Pack. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Niaspan Titration Starter Pack 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 Titration Starter Pack.

Niaspan Titration Starter Pack