Temovate

   
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Temovate


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

Dosage - SOLUTION; 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 - ALTANA
The firm name holding legal responsibility for Temovate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019966
The FDA assigned number to Temovate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Temovate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Feb 22, 1990
The date Temovate 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 Temovate. 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 Temovate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Altana Inc
The full name of the firm holding legal responsibility for the new application of Temovate.

Temovate