Finacea
Drug - Finacea
The trade name of the product as shown on the labeling.
Dosage -
GEL; TOPICAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Azelaic Acid
Multiple ingredients are in alphabetical order.
Strength -
15%
The potency of the active ingredient(s), Azelaic Acid. May repeat for multiple part products.
Applicant -
INTENDIS
The firm name holding legal responsibility for Finacea. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021470
The FDA assigned number to Finacea. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Finacea. 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 -
Dec 24, 2002
The date Finacea 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 Finacea. 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 Finacea is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Intendis Inc
The full name of the firm holding legal responsibility for the new application of Finacea.
Finacea
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