Sensipar

   
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Sensipar


Drug - Sensipar
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) - Cinacalcet Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 60MG BASE
The potency of the active ingredient(s), Cinacalcet Hydrochloride. May repeat for multiple part products.

Applicant - AMGEN
The firm name holding legal responsibility for Sensipar. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021688
The FDA assigned number to Sensipar. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Sensipar. 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 - Mar 8, 2004
The date Sensipar 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 Sensipar. 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 Sensipar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Amgen Inc
The full name of the firm holding legal responsibility for the new application of Sensipar.

Sensipar