ANDA Suitability Petition for Levetiracetam Injection 1000 mg/Vial

Docket ID: FDA-2011-P-0186
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Status: OPEN
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): cder, 1000 mg/Vial, Injection , Levetiracetam , ANDA Suitability
Type: Nonrulemaking
Center: CDER
Docket Item Code: P

Primary Documents

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Posted: 08/16/2011
ID: FDA-2011-P-0186-0006
Posted: 04/04/2011
ID: FDA-2011-P-0186-0001
Comment Period Closed
Posted: 04/04/2011
ID: FDA-2011-P-0186-0004

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 04/04/2011
ID: FDA-2011-P-0186-0003
Comments Not Accepted
Supporting & Related Material
Posted: 04/04/2011
ID: FDA-2011-P-0186-0002


View All  (1)

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.