Derma-smoothe/fs

   
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Derma-smoothe/fs


Drug - Derma-smoothe/fs
The trade name of the product as shown on the labeling.

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

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

Strength - 0.01%
The potency of the active ingredient(s), Fluocinolone Acetonide. May repeat for multiple part products.

Applicant - HILL DERMAC
The firm name holding legal responsibility for Derma-smoothe/fs. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019452
The FDA assigned number to Derma-smoothe/fs. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Derma-smoothe/fs. 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 - Feb 3, 1988
The date Derma-smoothe/fs 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 Derma-smoothe/fs. 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 Derma-smoothe/fs is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hill Dermaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Derma-smoothe/fs.

Derma-smoothe/fs