Ditropan Xl

   
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Ditropan Xl


Drug - Ditropan 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) - Oxybutynin Chloride
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020897
The FDA assigned number to Ditropan Xl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ditropan 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 - Dec 16, 1998
The date Ditropan 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 Ditropan 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 Ditropan Xl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alza Corp
The full name of the firm holding legal responsibility for the new application of Ditropan Xl.

Ditropan Xl