Tegretol-xr

   
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Tegretol-xr


Drug - Tegretol-xr
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) - Carbamazepine
Multiple ingredients are in alphabetical order.

Strength - 400MG
The potency of the active ingredient(s), Carbamazepine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020234
The FDA assigned number to Tegretol-xr. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Tegretol-xr. 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 25, 1996
The date Tegretol-xr 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 Tegretol-xr. 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 Tegretol-xr 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 Tegretol-xr.

Tegretol-xr