Viracept

   
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Viracept


Drug - Viracept
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) - Nelfinavir Mesylate
Multiple ingredients are in alphabetical order.

Strength - EQ 250MG BASE
The potency of the active ingredient(s), Nelfinavir Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020779
The FDA assigned number to Viracept. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Viracept. 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 14, 1997
The date Viracept 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 Viracept. 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 Viracept is in. Format is RX, OTC, DISCN.

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

Viracept