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  7. Activities Report of the Generic Drugs Program (FY 2015)
  1. Types of Applications

Activities Report of the Generic Drugs Program (FY 2015)

Activities Report of the Generic Drugs Program (FY 2015)

GDUFA YEAR/Actions This Month14-Oct14-Nov14-Dec15-Jan15-Feb15-Mar15-Apr15-May15-Jun15-Jul15-Aug15-SepFY-2015
Refuse to Receive (RTR) +1211153027131115 20 13 19 50 236
Withdrawals6122117172311 21 16 18 26 170
Approvals4528292527194947 57 47 58 61 492
Tentative Approvals107551361913 10 12 6 14 120
Complete Responses (CR) +4376961041089411597 116 134 96 101 1180
Drug Master File Completeness Assessment (DMF CA)12455719286557662 65 54 35 105 880
GDUFA YEAR (Receipts)Submissions This Month14-Oct14-Nov14-Dec15-Jan15-Feb15-Mar15-Apr15-May15-Jun15-Jul15-Aug15-SepFY-2015
Abbreviated New Drug Applications (ANDA) ++5027432729575849 39 52 33 75 539
CBE Supplements +473385434411420439413474 472 425 549 466 5361
PAS Supplements +4522513337553848 37 41 28 45 480
GDUFA YEAR/ (Receipts)Amendments14-Oct14-Nov14-Dec15-Jan15-Feb15-Mar15-Apr15-May15-Jun15-Jul15-Aug15-SepFY-2015
Originals (Pre FY15) Administrative119228388339429372       
Originals (Pre FY15) Solicited (CR, ECD/IR)8680178320582503       
Originals (Pre FY15) Unsolicited39822910811884130       
Originals (FY15) Administrative12120302123       
Originals (FY15) Tier 1000001       
Originals (FY15) Tier 2000001       
Originals (FY15) Tier 3000000       
Originals (FY15) ECD/IR074433754       
PAS Supplements (Pre FY15) Administrative5211518149       
PAS Supplements (Pre FY15) Solicited (CR, ECD/IR)473588454253       
PAS Supplements (Pre FY15) Unsolicited43211111109       
PAS Supplements (FY15) Administrative163727       
PAS Supplements (FY15) Tier 1000001       
PAS Supplements (FY15) Tier 2000010       
PAS Supplements (FY15) Tier 3000000       
PAS Supplements (FY15) ECD/IR00341128       
CBE Amendments (all years together)6134297271101       
GDUFA YEAR (Receipts)14-Oct14-Nov14-Dec15-Jan15-Feb15-Mar15-Apr15-May15-Jun15-Jul15-Aug15-SepFY-2015
Controls +++11286111115104140136124 141 170 127 106 1472
GDUFA Post CR Meeting Requests ++++848996105113123129132 134 137 140 140 
Post CR Meeting Requests This month057981063 2 3 3 056

+ = Revised to reflect more accurate counting by the GDRP. For example RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.
++ = Starting FY15 ANDA Original Receipts are reported as raw receipts (versus filed receipts).
+++ = FY 15 Controls have been revised to count only those requests appropriate for a control.
++++ = Cumulative and NOT specific to the month. DMF raw receipts have been eliminated since DMF Completeness Assessments present a more accurate indication of workload.
Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes.
Note: Amendment metrics for April, May, June, July, August and September will be forthcoming