Vaniqa
Drug - Vaniqa
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) -
Eflornithine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
13.9%
The potency of the active ingredient(s), Eflornithine Hydrochloride. May repeat for multiple part products.
Applicant -
SKINMEDICA
The firm name holding legal responsibility for Vaniqa. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021145
The FDA assigned number to Vaniqa. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Vaniqa. 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 -
Jul 27, 2000
The date Vaniqa 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 Vaniqa. 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 Vaniqa is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Skinmedica Inc
The full name of the firm holding legal responsibility for the new application of Vaniqa.
Vaniqa
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