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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210166
Company: TAKEDA PHARMS USA

Products on NDA 210166

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOTEGRITY	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
MOTEGRITY	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210166Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210166Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2025	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210166s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210166Orig1s004ltr.pdf
11/09/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210166s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210166Orig1s002ltr.pdf

Labels for NDA 210166

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2025	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210166s004lbl.pdf
11/09/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210166s002lbl.pdf
12/14/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf

Therapeutic Equivalents for NDA 210166

MOTEGRITY

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOTEGRITY	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	210166	TAKEDA PHARMS USA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218295	ALKEM LABS LTD
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218812	AMNEAL
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	219160	ANNORA PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218977	APOTEX
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218963	APPCO
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	219216	H2-PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	217662	HIKMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218847	LUPIN LTD
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218177	MSN
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218492	NOVITIUM PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	219078	SOMERSET THERAP
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	219193	SPECGX LLC
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218795	ZENARA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218056	ZYDUS LIFESCIENCES

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOTEGRITY	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	Yes	AB	210166	TAKEDA PHARMS USA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218295	ALKEM LABS LTD
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218812	AMNEAL
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	219160	ANNORA PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218977	APOTEX
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218963	APPCO
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	219216	H2-PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	217662	HIKMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218847	LUPIN LTD
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218177	MSN
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218492	NOVITIUM PHARMA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	219078	SOMERSET THERAP
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	219193	SPECGX LLC
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218795	ZENARA
PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218056	ZYDUS LIFESCIENCES

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