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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218795

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NDA 218795 describes PRUCALOPRIDE SUCCINATE, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Apotex, Appco, H2-pharma, Hikma, Lupin Ltd, MSN, Novitium Pharma, Somerset Therap, Specgx Llc, Torrent, Zenara, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from thirteen suppliers. Additional details are available on the PRUCALOPRIDE SUCCINATE profile page.

The generic ingredient in PRUCALOPRIDE SUCCINATE is prucalopride succinate. Fourteen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.

Summary for 218795

Tradename:	PRUCALOPRIDE SUCCINATE
Applicant:	Zenara
Ingredient:	prucalopride succinate
Patents:	0

Pharmacology for NDA: 218795

Mechanism of Action	Serotonin 4 Receptor Agonists

Suppliers and Packaging for NDA: 218795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	218795	ANDA	Cipla USA Inc.	69097-218	69097-218-02	30 TABLET, FILM COATED in 1 BOTTLE (69097-218-02)
PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	218795	ANDA	Cipla USA Inc.	69097-219	69097-219-02	30 TABLET, FILM COATED in 1 BOTTLE (69097-219-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jun 24, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jun 24, 2025	TE:	AB	RLD:	No

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