Leflunomide

   
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Leflunomide


Drug - Leflunomide
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) - Leflunomide
Multiple ingredients are in alphabetical order.

Strength - 20MG
The potency of the active ingredient(s), Leflunomide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 077090
The FDA assigned number to Leflunomide. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Leflunomide. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 13, 2005
The date Leflunomide 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 Leflunomide. 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 Leflunomide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apotex Corp
The full name of the firm holding legal responsibility for the new application of Leflunomide.

Leflunomide