Naftin

   
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Naftin


Drug - Naftin
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) - Naftifine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 1%
The potency of the active ingredient(s), Naftifine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019356
The FDA assigned number to Naftin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Naftin. 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 - Jun 18, 1990
The date Naftin 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 Naftin. 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 Naftin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merz Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Naftin.

Naftin