Clobex

   
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Clobex


Drug - Clobex
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Clobetasol Propionate
Multiple ingredients are in alphabetical order.

Strength - 0.05%
The potency of the active ingredient(s), Clobetasol Propionate. May repeat for multiple part products.

Applicant - DOW PHARM SCI
The firm name holding legal responsibility for Clobex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021835
The FDA assigned number to Clobex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Clobex. 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 - Oct 27, 2005
The date Clobex 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 Clobex. 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 Clobex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Dow Pharmaceutical Sciences
The full name of the firm holding legal responsibility for the new application of Clobex.

Clobex