Oralone

   
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Oralone


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

Dosage - PASTE; DENTAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.1%
The potency of the active ingredient(s), Triamcinolone Acetonide. May repeat for multiple part products.

Applicant - TARO
The firm name holding legal responsibility for Oralone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071383
The FDA assigned number to Oralone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Oralone. 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 - Jul 6, 1987
The date Oralone 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 Oralone. 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 Oralone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Taro Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Oralone.

Oralone