Generic Drugs Program Activities Report - Monthly Performance

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.         

Previous Activities Reports

• Activities Report of the Generic Drug Program (FY 2019)
• Activities Report of the Generic Drug Program (FY 2018)
• Activities Report of the Generic Drug Program (FY 2017)
• Activities Report of the Generic Drug Program (FY 2016)
• Activities Report of the Generic Drug Program (FY 2015)
• Activities Report of the Generic Drug Program (FY 2014)
• Activities Report of the Generic Drug Program (FY 2013)