APIXABAN | A209845 | BRECKENRIDGE PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3, SUPPLEMENT TO ANDA - Proposed Prescribing Information for Apix... FDA-2016-P-3463 Axinn, Veltrop & Harkrider LLP filed a suitability petition regarding proposed prescribing information for apixaban tablets as a supplement to an Abbreviated New Drug Application, seeking FDA review and approval of the proposed labeling for this generic anticoagulant product. | Suitability | 2016-10-25 | Open | Axinn |
Attachment 3 Proposed Prescribing Information for Apixaban Tablets re Suitabi... FDA-2016-P-3463 I cannot provide a summary of this FDA citizen petition based on the information provided. The document excerpt contains only a title and header indicating this is proposed prescribing information for apixaban tablets related to a suitability petition filed by the law firm Axinn, Veltrop & Harkrider | Suitability | 2016-10-21 | Open | Axinn |
Attachment 1 FDA Orange Book page for Eliquis® (apixaban) tablets, 2.5 mg and... FDA-2016-P-3463 The law firm Axinn, Veltrop & Harkrider LLP filed a petition regarding Eliquis (apixaban) tablets in 2.5 mg and 5 mg strengths, requesting determination of suitability for abbreviated new drug application (ANDA) approval based on the Orange Book listing for this anticoagulant product. | Suitability | 2016-10-21 | Open | Axinn |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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