Confirm that the Agency Will Stay Approval for 30 months from July 26, 2010 of Abbreviated New Drug Application No. 78-998-CLOSED

 
Docket ID: FDA-2010-P-0518
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: CLOSE Closed per letter of 2/22/1011
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Confirm that the Agency Will Stay Approval for 30 months from July 26, 2010 of Abbreviated New Drug Application No. 78-998
Keyword(s): CDER, 814 Patent, Boniva, ANDA 78-998, CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (4)
Comment Period Closed
Other
Posted: 02/22/2011
ID: FDA-2010-P-0518-0014
Comment Period Closed
Other
Posted: 11/22/2010
ID: FDA-2010-P-0518-0012
Comment Period Closed
Other
Posted: 10/25/2010
ID: FDA-2010-P-0518-0008
Comment Period Closed
Other
Posted: 10/25/2010
ID: FDA-2010-P-0518-0001

Supporting Documents

View All  (7)
Comments Not Accepted
Supporting & Related Material
Posted: 11/22/2010
ID: FDA-2010-P-0518-0013
Comments Not Accepted
Supporting & Related Material
Posted: 10/25/2010
ID: FDA-2010-P-0518-0003
Comments Not Accepted
Supporting & Related Material
Posted: 10/25/2010
ID: FDA-2010-P-0518-0007

Comments

View All  (3)

3
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.