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withdrawn,object_id FDA-2007-D-0369-0310,FDA,FDA-2007-D-0369,Draft and Revised Draft Guidances for Industry Describing Product Specific Bioequivalence Recommendations Availability,Notice,Notice of Availability,2014-12-30T05:00:00Z,2014,12,2014-12-30T05:00:00Z,2015-03-03T04:59:59Z,2024-11-12T05:29:27Z,2014-30514,1,0,0900006481999bc7 FDA-2007-D-0369-0309,FDA,FDA-2007-D-0369,"Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2014-12-24T05:00:00Z,2014,12,2014-12-24T05:00:00Z,2015-02-24T04:59:59Z,2015-02-24T03:14:02Z,2014-30109,0,0,09000064819910d4 FDA-2007-D-0369-0308,FDA,FDA-2007-D-0369,"Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2014-12-11T05:00:00Z,2014,12,2014-12-11T05:00:00Z,2015-02-10T04:59:59Z,2015-02-10T03:01:55Z,2014-29035,0,0,090000648196d9d1 FDA-2007-D-0369-0298,FDA,FDA-2007-D-0369,"Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2014-11-06T05:00:00Z,2014,11,2014-11-06T05:00:00Z,2015-01-06T04:59:59Z,2015-01-07T03:02:51Z,2014-26306,0,0,090000648191ac5d FDA-2007-D-0369-0297,FDA,FDA-2007-D-0369,"Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2014-09-22T04:00:00Z,2014,9,2014-09-22T04:00:00Z,2014-11-22T04:59:59Z,2014-09-22T15:04:24Z,2014-22450,0,0,0900006481885a9f FDA-2007-D-0369-0296,FDA,FDA-2007-D-0369,Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability,Notice,Notice of Availability,2014-07-23T04:00:00Z,2014,7,2014-07-23T04:00:00Z,2014-09-23T03:59:59Z,2014-09-18T01:03:32Z,2014-17293,0,0,09000064817d75b7 FDA-2007-D-0369-0292,FDA,FDA-2007-D-0369,Attachment 1 List of Attachments re Comment from Alkermes Inc,Supporting & Related Material,Background Material,2014-06-20T04:00:00Z,2014,6,,,2014-11-04T16:39:57Z,,0,0,0900006481734fe8 FDA-2007-D-0369-0294,FDA,FDA-2007-D-0369,Tab 1 FDA Draft Guidance on Naltrexone re Comment from Alkermes Inc,Supporting & Related Material,Background Material,2014-06-20T04:00:00Z,2014,6,,,2014-11-04T16:45:18Z,,0,0,09000064817355c1 FDA-2007-D-0369-0293,FDA,FDA-2007-D-0369,Attachment 2 Appendix re Comment from Alkermes Inc,Supporting & Related Material,Background Material,2014-06-20T04:00:00Z,2014,6,,,2014-11-04T16:41:04Z,,0,0,0900006481734fea FDA-2007-D-0369-0290,FDA,FDA-2007-D-0369,"Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability",Notice,Notice of Availability,2014-04-02T04:00:00Z,2014,4,2014-04-02T04:00:00Z,2014-06-03T03:59:59Z,2014-11-27T03:01:03Z,2014-07330,0,0,0900006481697913