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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218492
Company: NOVITIUM PHARMA

Products on ANDA 218492

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218492

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218492Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 218492

PRUCALOPRIDE SUCCINATE

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	219220	AJANTA PHARMA LTD
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	219220	AJANTA PHARMA LTD
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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