Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
| Prescription | 008 |
Application Products
| 001 | CAPSULE;ORAL | 25MG | 1 | LYRICA | PREGABALIN |
| 002 | CAPSULE;ORAL | 50MG | 1 | LYRICA | PREGABALIN |
| 003 | CAPSULE;ORAL | 75MG | 1 | LYRICA | PREGABALIN |
| 004 | CAPSULE;ORAL | 100MG | 1 | LYRICA | PREGABALIN |
| 005 | CAPSULE;ORAL | 150MG | 1 | LYRICA | PREGABALIN |
| 006 | CAPSULE;ORAL | 200MG | 1 | LYRICA | PREGABALIN |
| 007 | CAPSULE;ORAL | 225MG | 1 | LYRICA | PREGABALIN |
| 008 | CAPSULE;ORAL | 300MG | 1 | LYRICA | PREGABALIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-12-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-02-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-02-17 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-10-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2007-06-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-01-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2010-10-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2011-04-26 | UNKNOWN |
| REMS; REMS | SUPPL | 24 | AP | 2011-04-26 | N/A |
| LABELING; Labeling | SUPPL | 25 | AP | 2011-08-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2011-06-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2012-06-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2013-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2016-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2016-07-08 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 32 | AP | 2016-12-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2018-05-03 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2019-05-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 40 | AP | 2020-04-03 | STANDARD |
Submissions Property Types
| SUPPL | 14 | Null | 7 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 4 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 40 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
| 007 | Prescription | AB |
| 008 | Prescription | AB |
CDER Filings
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(
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[companyName] =>
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[labels] =>
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[supplements] =>
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)
)