Tarceva

   
Google
 
Web NewDrugInformation.com

Tarceva


Drug - Tarceva
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) - Erlotinib Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 150MG BASE
The potency of the active ingredient(s), Erlotinib Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021743
The FDA assigned number to Tarceva. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Tarceva. 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 - Nov 18, 2004
The date Tarceva 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 Tarceva. 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 Tarceva is in. Format is RX, OTC, DISCN.

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

Tarceva