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 *          7
Standard - GDUFA II6 *          6
Priority - GDUFA II1 *          1
GDUFA I0 *          0
Acknowledgement - Original54 *          54
Refuse to Receive (RTR) - PAS0 *          0
Withdrawals  (all original ANDAs)54 *          54
Approved ANDA31 *          31
Unapproved ANDA23 *          23
Withdrawals  (PAS)12 *          12
Approvals 110 99          209
   First Cycle Approvals (included above)24 *          24
Tentative Approvals18 29          47
    First Cycle Tentative Approvals (included above)5 *          5
Complete Responses (CR)175 230          405
Information Requests (IR)372 *          372
Originals247 *          247
Supplements125 *          125
Discipline Review Letters (DRL)180 *          180
Drug Master File Completeness Assessment (DMF CA)55 *          55
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 *          225
Major134 *          134
Minor90 *          90
Unsolicited Amendment1 *          1
Pre-Submission Facility Correspondence12 *          12
CBE Supplements 596 *          596
PAS Supplements ++76 *          76
DMFs - Type II74 *          74
GDUFA YEAR (Receipts)18-Oct18-Nov18-Dec19-Jan19-Feb19-Mar19-Apr19-May19-Jun19-Jul19-Aug19-SepFY-2019
Controls +++240 *          240
Requests for Clarfication4 *          4
Post CR Meeting Requests This month5 *          5

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.
 

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