Orap

   
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Orap


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

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

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

Strength - 2MG
The potency of the active ingredient(s), Pimozide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 017473
The FDA assigned number to Orap. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Orap. 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 - Jul 31, 1984
The date Orap 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 Orap. 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 Orap is in. Format is RX, OTC, DISCN.

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

Orap