Oxybutynin Chloride

   
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Oxybutynin Chloride


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

Strength - 5MG
The potency of the active ingredient(s), Oxybutynin Chloride. May repeat for multiple part products.

Applicant - USL PHARMA
The firm name holding legal responsibility for Oxybutynin Chloride. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074625
The FDA assigned number to Oxybutynin Chloride. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Oxybutynin Chloride. 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 - Jul 31, 1996
The date Oxybutynin Chloride 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 Oxybutynin Chloride. 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 Oxybutynin Chloride is in. Format is RX, OTC, DISCN.

Applicant Full Name - Usl Pharma Inc
The full name of the firm holding legal responsibility for the new application of Oxybutynin Chloride.

Oxybutynin Chloride