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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 219220

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NDA 219220 describes PRUCALOPRIDE SUCCINATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Apotex, Appco, H2-pharma, Hikma, Lupin Ltd, MSN, Novitium Pharma, Somerset Therap, Specgx Llc, Teva Pharms Inc, Torrent, Zenara, and Zydus Lifesciences, and is included in seventeen NDAs. It is available from sixteen suppliers. Additional details are available on the PRUCALOPRIDE SUCCINATE profile page.

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

Summary for 219220

Tradename:	PRUCALOPRIDE SUCCINATE
Applicant:	Ajanta Pharma Ltd
Ingredient:	prucalopride succinate
Patents:	0

Pharmacology for NDA: 219220

Mechanism of Action	Serotonin 4 Receptor Agonists

Suppliers and Packaging for NDA: 219220

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	219220	ANDA	Ajanta Pharma USA Inc.	27241-294	27241-294-30	30 TABLET in 1 BOTTLE (27241-294-30)
PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	219220	ANDA	Ajanta Pharma USA Inc.	27241-295	27241-295-30	30 TABLET in 1 BOTTLE (27241-295-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jan 16, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jan 16, 2026	TE:	AB	RLD:	No

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