Fluocinonide Emulsified Base

   
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Fluocinonide Emulsified Base


Drug - Fluocinonide Emulsified Base
The trade name of the product as shown on the labeling.

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

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

Strength - 0.05%
The potency of the active ingredient(s), Fluocinonide. May repeat for multiple part products.

Applicant - ALTANA
The firm name holding legal responsibility for Fluocinonide Emulsified Base. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076586
The FDA assigned number to Fluocinonide Emulsified Base. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fluocinonide Emulsified Base. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 23, 2004
The date Fluocinonide Emulsified Base 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 Fluocinonide Emulsified Base. 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 Fluocinonide Emulsified Base is in. Format is RX, OTC, DISCN.

Applicant Full Name - Altana Inc
The full name of the firm holding legal responsibility for the new application of Fluocinonide Emulsified Base.

Fluocinonide Emulsified Base