Nix
Drug - Nix
The trade name of the product as shown on the labeling.
Dosage -
LOTION; TOPICAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Permethrin
Multiple ingredients are in alphabetical order.
Strength -
1%
The potency of the active ingredient(s), Permethrin. May repeat for multiple part products.
Applicant -
GLAXOSMITHKLINE
The firm name holding legal responsibility for Nix. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019435
The FDA assigned number to Nix. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Nix. 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 -
Mar 31, 1986
The date Nix 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 Nix. 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 Nix is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Nix.
Nix
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