Artane

   
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Artane


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

Dosage - ELIXIR; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Trihexyphenidyl Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2MG/5ML
The potency of the active ingredient(s), Trihexyphenidyl Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 006773
The FDA assigned number to Artane. Format is nnnnnn.

Product Number - 009
The FDA assigned number to identify Artane. 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 - Approved Prior to Jan 1, 1982
The date Artane 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 Artane. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Artane is in. Format is RX, OTC, DISCN.

Applicant Full Name - Lederle Laboratories Div American Cyanamid Co
The full name of the firm holding legal responsibility for the new application of Artane.

Artane