Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021446
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21446ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021446s041,022488s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021446Orig1s041,%20022488Orig1s018,%20209501Orig1s005Correctedltr.pdf | |
| 04/03/2020 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021446Orig1s040, 022488Orig1s017ltr.pdf | |
| 05/23/2019 | SUPPL-36 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021446Orig1s036ltr, 022488Orig1s014ltr.pdf | |
| 05/03/2018 | SUPPL-35 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021446Orig1s035,022488Orig1s013ltr.pdf | |
| 12/22/2016 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s032, 022488Orig1s011ltr.pdf | |
| 07/08/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2016 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf | |
| 12/23/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf | |
| 06/20/2012 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021446s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028SumR.pdf | |
| 06/20/2011 | SUPPL-26 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf | |
| 08/24/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf | |
| 04/26/2011 | SUPPL-24 | REMS-Modified, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf | |
| 04/26/2011 | SUPPL-23 | REMS-Modified, Labeling-Medication Guide, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf | |
| 10/08/2010 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021446s021ltr.pdf | |
| 01/04/2010 | SUPPL-18 | Labeling-Medication Guide, REMS-Assessment, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf | |
| 04/23/2009 | SUPPL-14 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf | |
| 04/23/2009 | SUPPL-13 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf | |
| 06/21/2007 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021446s010ltr.pdf | |
| 10/27/2006 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s006ltr.pdf |
| 02/17/2006 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf | |
| 02/17/2006 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021446s041,022488s018lbl.pdf | |
| 04/03/2020 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf | |
| 05/23/2019 | SUPPL-36 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf | |
| 05/03/2018 | SUPPL-35 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf | |
| 12/22/2016 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf | |
| 03/09/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf | |
| 12/23/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf | |
| 06/20/2012 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf | |
| 08/24/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf | |
| 06/20/2011 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf | |
| 04/26/2011 | SUPPL-24 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-24 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 10/08/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf | |
| 01/04/2010 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 01/04/2010 | SUPPL-18 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 01/04/2010 | SUPPL-18 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 04/23/2009 | SUPPL-14 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-13 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 06/21/2007 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf | |
| 02/17/2006 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf | |
| 02/17/2006 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf |
LYRICA
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091219 | TEVA PHARMS |
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091219 | TEVA PHARMS |
CAPSULE;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210891 | YILING |
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 225MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210891 | YILING |