Proposals to Refuse to Approve Supplemental New Drug Applications: Bromday (Bromfenac Ophthalmic Solution), 0.09; Opportunity for Hearing

Document ID: FDA-2011-N-0513-0002
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-19566
View Document:

Details Information

Abstract:	Request for Hearing due 9/2/11 Data in Support the Hearing due 10/3/11
Document Subtype:	Notice of Opportunity of Hearing
Received Date:	August 02 2011, at 12:00 AM Eastern Daylight Time
Start-End Page:	46820 - 46822
Page Count:	3
Comment Start Date:	August 3 2011, at 12:00 AM Eastern Standard Time
Comment Due Date:	October 3 2011, at 11:59 PM Eastern Standard Time

Total: 3

ISTA Pharmaceuticals, Inc. - Request for Hearing
Posted: 09/07/2011 ID: FDA-2011-N-0513-0003

Comment Period Closed
Oct 03,2011 11:59 PM ET

ISTA Pharmaceuticals, Inc. - Comment
Posted: 10/17/2011 ID: FDA-2011-N-0513-0005

Comment Period Closed
Oct 03,2011 11:59 PM ET

Exhibits to Submission of ISTA Pharmaceuticals, Inc.
Posted: 10/17/2011 ID: FDA-2011-N-0513-0006

Comment Period Closed
Oct 03,2011 11:59 PM ET