Activities Report of the Generic Drug Program (FY 2016)

GDUFA YEAR/Actions This Month	15-Oct	15-Nov	15-Dec	16-Jan	16-Feb	16-Mar	16-Apr	16-May	16-Jun	16-Jul	16-Aug	16-Sep	FY-2016
Refuse to Receive (RTR) +	12	19	11	29	33	18	31	40	13	14	17	9	246
Withdrawals (all original ANDAs)	18	19	14	48	27	20	20	8	34	13	12	15	248
Approvals +	50	61	79	43	51	60	53	55	51	46	51	51	651
Tentative Approvals +	22	6	20	17	12	16	16	20	15	10	14	16	184
Complete Responses (CR) +	105	92	113	103	129	147	190	151	166	169	167	193	1725
Drug Master File Completeness Assessment (DMF CA)	111	57	132	61	96	65	84	60	51	83	38	48	886

GDUFA YEAR (Receipts)Submissions This Month	15-Oct	15-Nov	15-Dec	16-Jan	16-Feb	16-Mar	16-Apr	16-May	16-Jun	16-Jul	16-Aug	16-Sep	FY-2016
Abbreviated New Drug Applications (ANDA) ++	35	42	180	40	61	114	56	58	78	69	60	59	852
CBE Supplements	623	374	386	348	410	506	540	426	499	357	519	678	5666
PAS Supplements	34	33	47	32	45	35	33	43	39	33	71	33	478

GDUFA YEAR (Receipts)Submissions This Month	15-Oct	15-Nov	15-Dec	16-Jan	16-Feb	16-Mar	16-Apr	16-May	16-Jun	16-Jul	16-Aug	16-Sep	FY-2016
Controls +++	158	101	118	126	157	204	134	186	219	168	154	158	1883
GDUFA Post CR Meeting Requests ++++	141	143	146	148	153	156	161	163	166	169	174	176
Post CR Meeting Requests this month	1	2	3	2	5	3	5	2	3	3	5	2	36

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.
+ = Revised to reflect more accurate counting by our tracking systems. For example, RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.
++ = Starting FY15, ANDA Original Receipts are reported as raw receipts (versus filed receipts).
+++ = Controls have been revised to count only those requests deemed appropriate for a control.
++++ = Cumulative and NOT specific to the month.

Previous Reports

• Activities Report of the Generic Drug Program (FY 2016)
• Activities Report of the Generic Drugs Program (FY 2015)
• Activities Report of the Generic Drugs Program (FY 2014)
• Activities Report of the Generic Drug Program (FY 2013)