Oruvail

NDA 19816, held by Wyeth Pharms Inc. Ketoprofen.

As of Nov 13, 2026, NDA 19816 (Oruvail), held by Wyeth Pharms Inc, was first approved by FDA on Sep 24, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 24, 1993
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 24, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Oruvail200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Ketoprofen	DiscontinuedReference drug
Oruvail150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Ketoprofen	DiscontinuedReference drug
Oruvail100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Ketoprofen	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 8Labeling · Standard review	Approved	None posted
Jul 31, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 18, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 5, 1997	Supplement 7Labeling · Standard review	Approved	Review
Mar 21, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 21, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 21, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 10, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Sep 24, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19816
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters