U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drug Program (FY 2013)
  1. Types of Applications

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

Return to Generic Drugs: Information for Industry