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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022488
Company: UPJOHN

Medication Guide

Summary Review

Products on NDA 022488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYRICA	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022488

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
12/13/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022488s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021446Orig1s041, 022488Orig1s018, 209501Orig1s005Correctedltr.pdf
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-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	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

Labels for NDA 022488

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022488s18lbl.pdf
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-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-2	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 022488

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	UPJOHN
PREGABALIN	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	No	AA	207623	ALKEM LABS LTD
PREGABALIN	PREGABALIN	20MG/ML	SOLUTION;ORAL	Prescription	No	AA	212604	PATRIN

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