U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  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                       49
First Time Generics 6                       6
Not First Time Generics 43                       43
First Cycle Approvals 12                       12
Not First Cycle Approvals 37                       37
Tentative Approvals 14                       14
First Cycle Tentative Approvals (included above) 2                       2
Complete Responses (CR) 152                       152
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                       24
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
GDUFA YEAR (Receipts) 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
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

Back to Top