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  7. Generic Drugs Program Activities Report - Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Generic Drugs Program Activities Report - Monthly Performance

Fiscal Year 2020

 

GDUFA YEAR/
Actions This Month		 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Refuse to Receive (RTR) - Originals 1 *                     1
Standard - GDUFA II 1 *                     1
Priority - GDUFA II 0 *                     0
GDUFA I 0 *                     0
Acknowledgement - Original 37 *                     37
Refuse to Receive (RTR) - PAS 1 *                     1
Withdrawals  (all original ANDAs) 41 *                     41
Approved ANDA 1 *                     1
Unapproved ANDA 40 *                     40
Withdrawals  (PAS) 15 *                     15
Approvals  57 59                     116
   First Cycle Approvals (included above) 10 *                     10
Tentative Approvals  8 10                     18
    First Cycle Tentative Approvals (included above) 2 *                     2
Complete Responses (CR) 197 156                     353
Information Requests (IR) 340 *                     340
Originals 230 *                     230
Supplements 110 *                     110
Discipline Review Letters (DRL) 188 *                     188
Drug Master File Completeness Assessment (DMF CA) 41 *                     41

 

GDUFA YEAR (Receipts)Submissions This Month 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Abbreviated New Drug Applications (ANDA) + 59 57                     116
ANDA Amendments 254 *                     254
Major 86 *                     86
Minor 81 *                     81
Unsolicited Amendments** 87 *                     87
Pre-Submission Facility Correspondence 6 *                     6
CBE Supplements  721 *                     721
PAS Supplements ++  94 *                     94
DMFs - Type II 41 *                     41

 

GDUFA YEAR (Receipts) 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020
Controls +++ 292 *                     292
Requests for Clarfication 7 *                     7
Post CR Meeting Requests This Month 5 *                     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.
** = Due to system capabilities, counts for unsolicited amendments were previously based on amendments submitted after a tentative approval was issued. Starting in Oct. 2019 (FY 2020) the monthly metric report now captures all unsolicited amendments submitted to the agency.
+ = 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.         

Previous Activities Reports