Flavoxate Hcl

   
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Flavoxate Hcl


Drug - Flavoxate Hcl
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 - IMPAX PHARMS
The firm name holding legal responsibility for Flavoxate Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076234
The FDA assigned number to Flavoxate Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Flavoxate Hcl. 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 - Aug 28, 2003
The date Flavoxate Hcl 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 Flavoxate Hcl. 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 Flavoxate Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Impax Pharmaceuticals
The full name of the firm holding legal responsibility for the new application of Flavoxate Hcl.

Flavoxate Hcl