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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209501
Company: UPJOHN

Medication Guide

Products on NDA 209501

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYRICA CR	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
LYRICA CR	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
LYRICA CR	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209501Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209501Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209501s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021446Orig1s041,%20022488Orig1s018,%20209501Orig1s005Correctedltr.pdf
04/03/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209501s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209501Orig1s003ltr.pdf

Labels for NDA 209501

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209501s005lbl.pdf
04/03/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209501s003lbl.pdf
10/11/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf

Therapeutic Equivalents for NDA 209501

LYRICA CR

TABLET, EXTENDED RELEASE;ORAL; 82.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211593	ALVOGEN
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON
PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211889	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 165MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211593	ALVOGEN
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213313	APOTEX
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON
PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211889	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 330MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYRICA CR	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209501	UPJOHN
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211593	ALVOGEN
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213313	APOTEX
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214496	EPIC PHARMA LLC
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213226	MSN
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215249	RUBICON
PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211889	SUN PHARM

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