Drugs

Activities Report of the Generic Drug Program (FY 2014)

 

Actions This MonthOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Refuse to Receive (RTR)301016161487201291021 173
Withdrawals1975137118417173635 179
Approvals204030343438412044184545 409
Tentative Approvals410125777910677 91
Complete Responses (CR)11312611111411811210012090878875 1254
Drug Master File Complete Assessment (DMF CA)18115098192129130105156173160130102 1706

 

Submissions This MonthOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Abbreviated New Drug Applications (ANDA)41582258576112741346354425 1473
Amendments - Originals176156143139131160155153115134152164 1778
To Backlog ANDAs1521231141171091281221116797102115 1357
To Cohort Yr 1 ANDAs222725181526222217131718 242
To Cohort Yr 2 ANDAs264476112031243231 179
Amendments - Supplements216188266264192241264225212297298225 2888
To Backlog Prior Approval Supplements (PAS)282126593537442935374424 419
To Cohort Yr 1 PASs15102103918191120169 142
To Cohort Yr 2 PASs271838283339363733414444 418
Tier Amendments000000000000 0
Tier 1A000000000000 0
Tier 1B000000000000 0
Tier 1C000000000000 0
Tier 2000000000000 0
Drug Master Files (DMF)647510283691319278103807488 1039
Controls81906010876112946699112101109 1087
GDUFA Post CR Meeting Requests *252946495458636674778085 717

 

Status NumberOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Canceled223333333333 36
Complete141517222730353843505860 504
Denied223334555588 73
Granted014333225133 14
Pending7889108788881190
Post CR Meeting Requests This month638364436335 62

 

* = Cumulative and NOT specific to the month
Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes
 

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