Activities Report of the Generic Drug Program (FY 2013)

Actions This Month	Oct-12	Nov-12	Dec-12	Jan-13	Feb-13	Mar-13	Apr-13	May-13	Jun-13	Jul-13	Aug-13	Sep-13	Total Yr 1
Refuse to Receive (RTR)	9	10	4	14	10	15	16	2	17	14	19	20	150
Withdrawals	3	11	10	10	5	3	24	12	4	9	10	6	107
Approvals	35	34	39	29	43	49	41	32	31	45	31	31	440
Tentative Approvals	11	10	4	4	11	6	18	7	2	11	7	4	95
Complete Responses (CR)	126	130	125	97	104	73	104	96	94	92	105	105	1251
Drug Master File Complete Assessment (DMF CA)	18	127	76	189	154	144	147	124	121	178	202	219	1699

 

Submissions This Month	Oct-12	Nov-12	Dec-12	Jan-13	Feb-13	Mar-13	Apr-13	May-13	Jun-13	Jul-13	Aug-13	Sep-13	Total Yr 1
Abbreviated New Drug Applications (ANDA)	75	56	163	58	51	86	74	46	74	102	83	100	968
Amendments - Originals	183	147	132	176	151	145	183	150	142	146	149	189	1893
To Backlog ANDAs	182	145	127	173	148	137	173	137	129	124	134	162	1771
To Cohort Yr 1 ANDAs	1	2	5	3	3	8	10	13	13	22	15	27	122
To Cohort Yr 2 ANDAs	0	0	0	0	0	0	0	0	0	0	0	0
Amendments - Supplements	171	188	184	176	209	306	232	188	169	163	259	213	2458
To Backlog Prior Approval Supplements (PAS)	38	55	32	37	35	40	39	23	33	34	37	34	437
To Cohort Yr 1 PASs	3	13	41	35	39	58	39	45	22	14	53	54	416
To Cohort Yr 2 PASs	0	0	0	0	0	0	0	0	0	0	0	0
Tier Amendments	0	0	0	0	0	0	0	0	0	0	0	0
Tier 1A
Tier 1B
Tier 1C
Tier 2
Drug Master Files (DMF)	99	63	105	70	71	102	85	64	64	98	72	131	1024
Controls	77	46	56	62	84	74	93	101	106	115	83	56	953
GDUFA Post CR Meeting Requests *

 

Status Number	Oct-12	Nov-12	Dec-12	Jan-13	Feb-13	Mar-13	Apr-13	May-13	Jun-13	Jul-13	Aug-13	Sep-13	Total Yr 1
Canceled
Complete
Denied
Granted
Pending
Post CR Meeting Requests This month	0	1	0	0	1	0	4	4	4	2	3	4	23

* = Cumulative and NOT specific to the month

Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes

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