SUBMISSIONS BY MONTH	Oct-22	Nov-22	Dec-22	Jan-23	Feb-23	Mar-23	Apr-23	May-23	Jun-23	Jul-23	Aug-23	Sep-23	FY-2023
ANDAs *	26												26
Complex Products	5												5
Amendments	211												211
Major	55												55
Minor	50												50
Unsolicited	106												106
Requests for Reclassification of a Facility-Based Major CRL Amendment	4												4
Pre-Submission Facility Correspondence	11												11
Supplements	947												947
CBE	818												818
PAS**	129												129
DMF Payments	8												8
Controlled Correspondence ***	264												264
Level 1	235												235
Level 2	29												29
Controlled Correspondence Requests for Clarification	1												1
Product Development Meeting	7												7
Pre-Submission Meeting	0												0
PSG Teleconference	0												0
Pre-Submission PSG Meetings	0												0
Post-Submission PSG Meeting	0												0
Mid Cycle Review Meeting	1												1
Enhanced Mid Cycle Review Meeting	2												2
Post-CRL Clarification-Only Teleconference	3												3
Post-CRL Scientific Meeting	1												1

 

APPROVAL TIMES BY QUARTER *	Q1 (Oct - Dec 2023)	Q2 (Jan- Mar 2024)	Q3 (Apr - Jun 2024)	Q4 (Jul - Sept 2024)
Quarterly Mean Approval Times
Quarterly Median Approval Times
Quarterly Mean Tentative Approval Times
Quarterly Median Tentative Approval Times

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.
Indented metrics are included in the count of the non-indented metric above it.

Abbreviations:
PAS = Prior Approval Supplements
DMF = Drug Master File
CRL = Complete Response Letter
CBE = Changes Being Effected
PSG = Product-Specific Guidances

+ = Pending ANDAs Awaiting FDA Action are applications currently being reviewed by FDA.

++ = ANDAs Awaiting FDA Action and ANDAs Awaiting Applicant Action represent a snapshot in time for the status of distinct original ANDAs. Many of these applications have been reviewed and found “not approvable” in a previous cycle and have been resubmitted by the applicant for another cycle of review and assessment. These metrics are calculated at the end of the month or just thereafter.

+++ = ANDAs Awaiting Applicant TA are applications that have a status of ‘TA’ or Tentative Approval. If a generic drug product is ready for approval but cannot be approved due to a patent or exclusivity related to the reference listed drug product, FDA issues a tentative approval letter to the applicant, and the tentative approval letter details the basis for the tentative approval. A tentative approval does not allow the applicant to market the generic drug product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) delays final approval of the generic drug product until all patent or exclusivity issues have been resolved or, in some cases, until a 30-month stay associated with patent litigation has expired.

++++ = Applications Awaiting Applicant Action are applications that have a status of ‘CR’ or Complete Response. These applications have been reviewed by FDA and the data submitted are inadequate to support approval.

* = 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.

^ = Mean/ Median AP/TA calculated as the difference between the first full approval (AP) date or the first Tentative Approval (TA) date and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.

Previous Monthly Reports

• Activities Report of the Generic Drug Program (FY 2023)
• Activities Report of the Generic Drug Program (FY 2022)
• Activities Report of the Generic Drug Program (FY 2021)
• Activities Report of the Generic Drug Program (FY 2020)
• 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)

Previous Quarterly Reports

• FY 2022 | GDUFA II Quarterly Performance
• FY 2021 | GDUFA II Quarterly Performance
• FY 2020 | GDUFA II Quarterly Performance
• FY 2019 | GDUFA II Quarterly Performance
• FY 2018 | GDUFA II Quarterly Performance