Proposal to Refuse to Approve a Supplemental New Drug Application for Bromday (Bromfenac Ophthalmic Solution), 0.09%; Opportunity for a Hearing

Docket ID: FDA-2011-N-0513
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): cder, 0.09%, Bromfenac Ophthalmic Solution, Bromday
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: N

Primary Documents

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Comment Period Closed
Nov 10, 2011 11:59 PM ET
Posted: 07/13/2011
ID: FDA-2011-N-0513-0001
Comment Period Closed
Oct 03, 2011 11:59 PM ET
Posted: 08/03/2011
ID: FDA-2011-N-0513-0002
Comment Period Closed
Posted: 04/02/2012
ID: FDA-2011-N-0513-0017
Comment Period Closed
Posted: 02/21/2012
ID: FDA-2011-N-0513-0016
Comment Period Closed
Posted: 02/16/2012
ID: FDA-2011-N-0513-0015

Supporting Documents

No documents available.


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Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.