Oruvail

   
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Oruvail


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

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 200MG
The potency of the active ingredient(s), Ketoprofen. May repeat for multiple part products.

Applicant - WYETH PHARMS INC
The firm name holding legal responsibility for Oruvail. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019816
The FDA assigned number to Oruvail. Format is nnnnnn.

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

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

Approval Date - Sep 24, 1993
The date Oruvail 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 Oruvail. 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 Oruvail is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Oruvail.

Oruvail