Drugs

Activities Report of the Generic Drug 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     
Withdrawals6122117132311     
Approvals4528292527194947     
Tentative Approvals107551361913     
Complete Responses (CR) +4376961041089411597     
Drug Master File Completeness Assessment (DMF CA)12455719286557662     
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     
CBE Supplements +473385434411420439413474     
PAS Supplements +4522513337553848     
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     
GDUFA Post CR Meeting Requests ++++848996105113123129132     
Post CR Meeting Requests This month057981063     

+ = 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 and May will be forthcoming

Page Last Updated: 07/08/2015
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