Drugs

Activities Report of the Generic Drug Program (FY 2015)

GDUFA YEAR/
Actions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Refuse to Receive (RTR)63 18 30         
Withdrawals612 2 11         
Approvals4528 29 25         
Tentative Approvals107 5 5         
Complete Responses (CR)4376 95 104         
Drug Master File Completeness Assessment (DMF CA)12455 71 92         

GDUFA YEAR/
Submissions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Abbreviated New Drug Applications (ANDA)4927 43 27         
CBE Supplements476385435413         
PAS Supplements45224931         
GDUFA YEAR/
Amendments
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Originals (Pre FY15) Administrative119228 388 339         
Originals (Pre FY15) Solicited (CR, ECD/IR)8680 178 320         
Originals (Pre FY15) Unsolicited398229 108 118         
Originals (FY15) Administrative121 20 30         
Originals (FY15) Tier 100 0 0         

Originals (FY15) Tier 2

00 0 0         
Originals (FY15) Tier 3 00 0 0         
Originals (FY15) ECD/IR07 4 43         
PAS Supplements (Pre FY15) Administrative521 15 18         
PAS Supplements (Pre FY15) Solicited (CR, ECD/IR)4735 88 45         
PAS Supplements (Pre FY15) Unsolicited4321 11 11         
PAS Supplements (FY15) Administrative16 3 7         
PAS Supplements (FY15) Tier 100 0 0         
PAS Supplements (FY15) Tier 200 0 0         
PAS Supplements (FY15) Tier 300 0 0         
PAS Supplements (FY15) ECD/IR00 3 4         
CBE Amendments (all years together)61342972         
GDUFA YEAROct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Drug Master Files (DMF)9571 88 86         
Controls159128 141 166         
GDUFA Post CR Meeting Requests +8489 96 105         
Post CR Meeting Requests This month057 9         

+ = Cumulative and NOT specific to the month

** = Starting FY15 ANDA Original Receipts are reported as raw receipts (versus filed receipts).

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

 

Page Last Updated: 02/26/2015
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