id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2016-P-4587-0001,FDA,FDA-2016-P-4587,Citizen Petition from Mallinckrodt Pharmaceuticals,Other,Citizen Petition,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2017-05-13T21:06:17Z,,0,0,090000648243b8f5
FDA-2016-P-4587-0006,FDA,FDA-2016-P-4587,"Exhibit D Praxair Distribution, Inc. v. INO Therapeutics, LLC,
IPR2015-00884 (Patent 8,291,904 B2); IPR2015-00888 (Patent
8,776,794 B2); IPR2015-00889 (Patent 8,573,209 B2); IPR2015-00891
(Patent 8,573,210 B2); IPR2015-00893 (Patent 8,776795 B2),
Transcript of Proceedings May 16, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:32Z,,0,0,090000648243b8fc
FDA-2016-P-4587-0009,FDA,FDA-2016-P-4587,"Exhibit G Praxair Distribution, Inc. vs. Mallinckrodt Hospital Products IP Ltd, IPR 2015-00893 (Patent: 8,776,795 B2), Petitioner’s Reply to Patent Owners Response, Feb. 24, 2016 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:41Z,,0,0,090000648243b92e
FDA-2016-P-4587-0007,FDA,FDA-2016-P-4587,"Exhibit E Praxair Distribution, Inc. v. INO Therapeutics, LLC d/b/a Ikaria, Inc., Petition for Inter Partes Review of U.S. Patent No. 8,776,795, March 16, 2015 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:35Z,,0,0,090000648243b8fd
FDA-2016-P-4587-0010,FDA,FDA-2016-P-4587,"Exhibit H Tissue Debate Raises Fairness, Transparency Questions for Combo
Products, The Gray Sheet (4/29/2002) re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:44Z,,0,0,090000648243b92f
FDA-2016-P-4587-0002,FDA,FDA-2016-P-4587,Acknowledgement Letter from FDA DDM to Mallinckrodt Pharmaceuticals,Other,Acknowledgement Letter/Receipt,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T21:51:19Z,,0,0,090000648243b8f7
FDA-2016-P-4587-0005,FDA,FDA-2016-P-4587,"Exhibit C Import Alert # 89-04, Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System
Requirements (March 16, 2016) (Excerpt) re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:29Z,,0,0,090000648243b8fb
FDA-2016-P-4587-0003,FDA,FDA-2016-P-4587,"Exhibit A Transcript of Proceedings, Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
(Nov. 22, 1996) re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:22Z,,0,0,090000648243b8f9
FDA-2016-P-4587-0004,FDA,FDA-2016-P-4587,Exhibit B Life-threatening effects of discontinuing inhaled nitric oxide in severe respiratory failure. Am. J. Respir. Crit. Care Med. 1996:153;1985-87 re Citizen Petition from Mallinckrodt Pharmaceuticals,Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:25Z,,0,0,090000648243b8fa
FDA-2016-P-4587-0008,FDA,FDA-2016-P-4587,"Exhibit F Declaration of Robert T. Stone, Ph.D., IPR (unassigned, Patent: 8,291,904), March 13, 2015 re Citizen Petition from Mallinckrodt Pharmaceuticals",Supporting & Related Material,Background Material,2016-12-28T05:00:00Z,2016,12,,,2016-12-28T21:51:38Z,,0,0,090000648243b92d