Drugs

Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance

GDUFA YEAR/Actions This Month18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Refuse to Receive (RTR) - Originals7 44        15
Standard - GDUFA II6 33        12
Priority - GDUFA II1 11        3
GDUFA I0 00        0
Acknowledgement - Original54 9066        210
Refuse to Receive (RTR) - PAS0 01        1
Withdrawals  (all original ANDAs)54 919        82
Approved ANDA31 610        47
Unapproved ANDA23 39        35
Withdrawals  (PAS)12 23        17
Approvals 110 996981         359
   First Cycle Approvals (included above)24 1110        45
Tentative Approvals18 293121         99
    First Cycle Tentative Approvals (included above)5 62        13
Complete Responses (CR)175 230144206        755
Information Requests (IR)372 364290        1026
Originals247 249207        703
Supplements125 11583        323
Discipline Review Letters (DRL)180 254243        677
Drug Master File Completeness Assessment (DMF CA)55 5848        161
GDUFA YEAR (Receipts)
Submissions This Month
18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Abbreviated New Drug Applications (ANDA) +83 54*        137
ANDA Amendments225 187199        611
Major134 9790        321
Minor90 88101        279
Unsolicited Amendment1 28        11
Pre-Submission Facility Correspondence12 25        19
CBE Supplements 596 597604        1797
PAS Supplements ++76 6567        208
DMFs - Type II74 4463        181
GDUFA YEAR (Receipts)18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Controls +++240 246249        735
Requests for Clarification4 32        9
Post CR Meeting Requests This month5 178        30

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.

* = This data requires additional verification and will be posted when available.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).
++ = PAS Supplements do not include REMS PAS supplements.
+++ = Controls count only those requests deemed appropriate for a control.
 

Page Last Updated: 02/11/2019
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