Generic Drugs Program Monthly and Quarterly Activities Report

ACTIONS BY MONTH	Oct-25	Nov-25	Dec-25	Jan-26	FY-2026
Approvals	54	58	46	59	217
First-Time Generics	5	6	6	6	23
First-Cycle Approvals	15	6	7	17	45
Imminent Actions	11	8	4	13	36
Tentative Approvals	21	26	23	19	89
First-Cycle Tentative Approvals	2	6	5	5	18
Imminent Actions	7	12	6	4	29
Complete Responses	98	92	88	124	402
Original ANDAs Refuse-to-Receive	1	2	1	2	6
Standard	0	2	1	2	5
Priority	1	0	0	0	1
Original Acknowledgements	55	51	24	64	194
Withdrawals	84	10	13	27	134
Approved ANDAs	72	3	0	20	95
Unapproved ANDAs	12	7	13	7	39
PAS Approvals	114	122	158	138	532
PAS Refuse-to-Receives	1	0	0	0	1
PAS Withdrawals	7	13	16	18	54
Information Requests	494	473	495	414	1876
Originals	266	178	232	208	884
Supplements	228	295	263	206	992
Discipline Review Letters	172	119	107	154	552
DMF Completeness Assessments	53	52	20	31	156
Reclassifications of a Facility-Based Major CRL Granted	11	3	11	8	33
Reclassifications of a Facility-Based Major CRL Denied	0	0	2	0	2
Pending ANDAs Awaiting FDA Action +	1300	1272	1326	1265	--
ANDAs Awaiting Applicant Action ++	1880	1871	1845	1872	--
Tentative Approvals +++	575	585	585	581	--
Complete Responses ++++	1305	1286	1260	1291	--

SUBMISSIONS BY MONTH	Oct-25	Nov-25	Dec-25	Jan-26	FY-2026
ANDAs *	1	46	95	32	174
Complex Products	0	8	19	12	39
Amendments	161	198	184	168	711
Major	52	60	56	46	214
Minor	50	48	60	65	223
Unsolicited	59	90	68	57	274
Requests for Reclassification of a Facility-Based Major CRL Amendment	5	19	4	1	29
Pre-Submission Facility Correspondences	3	2	3	3	11
Supplements	875	768	922	933	3498
CBEs	727	639	717	813	2896
PASs **	148	129	205	120	602
DMF Payments	0	23	29	22	74
Controlled Correspondence ***	263	234	361	267	1125
Level 1	214	198	306	232	950
Level 2	49	36	55	35	175
Controlled Correspondence Requests for Clarification	1	0	0	1	2
Product Development Meeting	8	3	6	6	23
Pre-Submission Meetings	2	0	2	0	4
PSG Teleconferences	0	1	0	0	1
Pre-Submission PSG Meetings	0	0	0	0	0
Post-Submission PSG Meetings	0	0	0	0	0
Mid Cycle Review Meetings	0	0	0	0	0
Enhanced Mid Cycle Review Meetings	0	0	0	0	0
Post-CRL Clarification-Only Teleconference	7	4	5	5	21
Post-CRL Scientific Meeting	1	0	2	2	5

APPROVAL TIMES BY QUARTER ^	Q1 (Oct - Dec)	Q2 (Jan- Mar)	Q3 (Apr - Jun)	Q4 (Jul - Sept)
Quarterly Mean Approval Times	35.93
Quarterly Median Approval Times	25.65
Quarterly Mean Tentative Approval Times	45.83
Quarterly Median Tentative Approval Times	32.15

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.

Generic Drugs Program Monthly and Quarterly Activities Report

Note

Abbreviations

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