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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

GDUFA YEAR/
Actions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Refuse to Receive (RTR) - Originals 3 *                     3
Standard - GDUFA I3 3 *                     3
Priority - GDUFA II 0 *                     0
GDUFA I 0 *                     0
Acknowledgement - Original 61 *                     61
Refuse to Receive (RTR) - PAS 0 *                     0
Withdrawals (all original ANDAs) 201 *                     201
Approved ANDA 193 *                     193
Unapproved ANDA 8 *                     8
Withdrawals (PAS) 8 *                     8
Approvals 49 67                     116
First Time Generics 6 8                     14
Not First Time Generics 43 59                     102
First Cycle Approvals 12 *                     12
Not First Cycle Approvals 37 *                     37
Tentative Approvals 14 8                     22
First Cycle Tentative Approvals (included above) 2 *                     2
Complete Responses (CR) 152 168                     320
Information Requests (IR) 365 *                     365
Originals 210 *                     210
Supplements 155 *                     155
Discipline Review Letters (DRL) 188 *                     188
Drug Master File Completeness Assessment (DMF CA) 57 *                     57

 

GDUFA YEAR (Receipts)
Submissions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Abbreviated New Drug Applications (ANDA) + 24 51                     75
Amendments 220 *                     220
Major 95 *                     95
Minor 57 *                     57
Unsolicited Amendments ++ 68 *                     68
Pre-Submission Facility Correspondence 14 *                     14
CBE Supplements 811 *                     811
PAS Supplements +++ 120 *                     120
DMFs - Type II 49 *                     49
Controls ++++ 322 *                     322
Requests for Clarfication 1 *                     1
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.
+ = Original Receipts are reported as raw receipts (versus filed receipts).
++ = 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.
+++ = PAS Supplements do not include REMS PAS supplements.
++++ = Controls count only those requests deemed appropriate for a control.

Previous Activities Reports

 

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