Prialt

   
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Prialt


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

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

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

Strength - 200UGM/2ML (100MG/ML)
The potency of the active ingredient(s), Ziconotide. May repeat for multiple part products.

Applicant - ELAN PHARMS
The firm name holding legal responsibility for Prialt. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021060
The FDA assigned number to Prialt. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Prialt. 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 - Dec 28, 2004
The date Prialt 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 Prialt. 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 Prialt is in. Format is RX, OTC, DISCN.

Applicant Full Name - Elan Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Prialt.

Prialt