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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 *                       *
Standard - GDUFA II *                       *
Priority - GDUFA II *                       *
GDUFA I *                       *
Acknowledgement - Original *                       *
Refuse to Receive (RTR) - PAS *                       *
Withdrawals  (all original ANDAs) *                       *
Approved ANDA *                       *
Unapproved ANDA *                       *
Withdrawals  (PAS) *                       *
Approvals  57                       57
   First Cycle Approvals (included above) *                       *
Tentative Approvals  8                       8
    First Cycle Tentative Approvals (included above) *                       *
Complete Responses (CR) 197                       197
Information Requests (IR) *                       *
Originals *                       *
Supplements *                       *
Discipline Review Letters (DRL) *                       *
Drug Master File Completeness Assessment (DMF CA) *                       *
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) + 57                       57
ANDA Amendments *                       *
Major *                       *
Minor *                       *
Unsolicited Amendments** *                       *
Pre-Submission Facility Correspondence *                       *
CBE Supplements  *                       *
PAS Supplements ++  *                       *
DMFs - Type II *                       *
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 +++ *                       *
Requests for Clarfication *                       *
Post CR Meeting Requests This Month *                       *

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.
** = Unsolicited Amendments only include amendments submitted between review cycles.
+ = 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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