Urispas

   
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Urispas


Drug - Urispas
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) - Flavoxate Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 100MG
The potency of the active ingredient(s), Flavoxate Hydrochloride. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Urispas. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016769
The FDA assigned number to Urispas. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Urispas. 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 - Approved Prior to Jan 1, 1982
The date Urispas 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 Urispas. 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 Urispas 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 Urispas.

Urispas