Wellbutrin Xl

   
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Wellbutrin Xl


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 300MG
The potency of the active ingredient(s), Bupropion Hydrochloride. May repeat for multiple part products.

Applicant - SMITHKLINE BEECHAM
The firm name holding legal responsibility for Wellbutrin Xl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021515
The FDA assigned number to Wellbutrin Xl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Wellbutrin Xl. 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 - Aug 28, 2003
The date Wellbutrin Xl 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 Wellbutrin Xl. 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 Wellbutrin Xl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Smithkline Beecham Corp Dba Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Wellbutrin Xl.

Wellbutrin Xl