Gleevec

   
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Gleevec


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 100MG
The potency of the active ingredient(s), Imatinib Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021335
The FDA assigned number to Gleevec. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Gleevec. 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 - May 10, 2001
The date Gleevec 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 Gleevec. 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 Gleevec is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Gleevec.

Gleevec