Focalin Xr

   
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Focalin Xr


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

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

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

Strength - 10MG
The potency of the active ingredient(s), Dexmethylphenidate Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021802
The FDA assigned number to Focalin Xr. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Focalin 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 - May 26, 2005
The date Focalin 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) - No
The pioneer or innovator of Focalin 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 Focalin 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 Focalin Xr.

Focalin Xr