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  6. Abbreviated New Drug Application (ANDA)
  7. Generic Drugs Program Activities Report - Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Generic Drugs Program Activities Report - Monthly Performance

GDUFA YEAR/
Actions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Refuse to Receive (RTR) - Originals 3 3 3 3 9 3 5 5         34
Standard - GDUFA II 3 2 1 1 8 3 3 5         26
Priority - GDUFA II 0 1 2 2 1 0 2 0         8
GDUFA I 0 0 0 0 0 0 0 0         0
Acknowledgement - Original 61 63 45 83 91 62 70 94         569
Refuse to Receive (RTR) - PAS 0 1 0 0 0 0 1 0         2
Withdrawals (all original ANDAs) 201 5 31 17 10 25 30 25         344
Approved ANDA 193 0 18 12 2 15 4 16         260
Unapproved ANDA 8 5 13 5 8 10 26 9         84
Withdrawals (PAS) 8 7 24 5 18 8 10 7         87
Approvals 49 67 34 61 59 63 45 84         462
First Time Generics 6 8 5 7 7 14 11 30         88
Not First Time Generics 43 59 29 54 52 49 34 54         374
First Cycle Approvals 12 13 4 17 8 10 8 11         83
Not First Cycle Approvals 37 54 30 44 51 53 37 73         379
Tentative Approvals 14 8 22 19 12 18 17 10         120
First Cycle Tentative Approvals (included above) 2 0 2 1 2 0 3 0         10
Complete Responses (CR) 152 168 108 195 141 141 168 125         1198
Information Requests (IR) 365 353 308 377 422 466 324 409         3024
Originals 210 233 194 236 260 284 193 264         1874
Supplements 155 120 114 141 162 182 131 145         1150
Discipline Review Letters (DRL) 188 201 202 165 168 243 141 184         1492
Drug Master File Completeness Assessment (DMF CA) 57 73 38 42 44 58 36 32         380

 

GDUFA YEAR (Receipts)
Submissions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Abbreviated New Drug Applications (ANDA) + 24 51 135 61 50 125 64 74         584
Amendments 220 188 236 200 225 261 205 218         1753
Major 95 77 101 68 76 95 84 95         691
Minor 57 45 78 65 77 83 63 72         540
Unsolicited Amendments ++ 68 66 57 67 72 83 58 51         522
Pre-Submission Facility Correspondence 14 2 2 11 2 6 4 2         43
CBE Supplements 811 753 821 643 548 748 669 665         5658
PAS Supplements +++ 120 105 114 95 85 138 108 95         860
DMFs - Type II 49 50 77 55 58 82 48 52         471
Controls ++++ 322 332 252 318 341 347 349 306         2567
Requests for Clarfication 1 2 3 4 2 1 3 0         16
Post CR Meeting Requests This Month 5 3 5 3 4 4 7 4         35

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.
+ = Original Receipts are reported as raw receipts (versus filed receipts).
++ = Due to system capabilities, counts for unsolicited amendments were previously based on amendments submitted after a tentative approval was issued. Starting in Oct. 2019 (FY 2020) the monthly metric report now captures all unsolicited amendments submitted to the agency.
+++ = PAS Supplements do not include REMS PAS supplements.
++++ = Controls count only those requests deemed appropriate for a control.

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