Flutex

   
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Flutex


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

Dosage - OINTMENT; TOPICAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Triamcinolone Acetonide
Multiple ingredients are in alphabetical order.

Strength - 0.025%
The potency of the active ingredient(s), Triamcinolone Acetonide. May repeat for multiple part products.

Applicant - IVAX PHARMS
The firm name holding legal responsibility for Flutex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087375
The FDA assigned number to Flutex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Flutex. 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 - Nov 1, 1988
The date Flutex 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 Flutex. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Flutex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ivax Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Flutex.

Flutex