Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022488
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYRICA PREGABALIN 20MG/ML SOLUTION;ORAL Prescription AA 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
01/04/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488_lyrica_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2020 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040, 022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021446Orig1s040, 022488Orig1s017ltr.pdf
05/23/2019 SUPPL-14 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/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021446Orig1s036ltr,%20022488Orig1s014ltr.pdf
05/03/2018 SUPPL-13 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-11 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
03/09/2016 SUPPL-10 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-8 Labeling-Medication Guide 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
02/28/2013 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022488s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s007ltr.pdf
04/16/2012 SUPPL-6 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022488s006ltr.pdf
06/20/2011 SUPPL-5 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-4 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-3 Labeling 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-2 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide 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-1 Labeling-Medication Guide, REMS-Assessment, REMS-Modified 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040, 022488s017lbl.pdf
05/23/2019 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf
05/03/2018 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf
12/22/2016 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf
03/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf
12/23/2013 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf
02/28/2013 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022488s007lbl.pdf
08/24/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf
06/20/2011 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf
04/26/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-1 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
04/26/2011 SUPPL-1 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
01/04/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf

LYRICA

SOLUTION;ORAL; 20MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 20MG/ML SOLUTION;ORAL Prescription Yes AA 022488 PFIZER
PREGABALIN PREGABALIN 20MG/ML SOLUTION;ORAL Prescription No AA 207623 ALKEM LABS LTD

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