Last Updated: November 9, 2026

Details for New Drug Application (NDA): 219180

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NDA 219180 describes PRUCALOPRIDE SUCCINATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal, Annora Pharma, Apotex, Appco, Bionpharma, Hikma, Lupin, Micro Labs, MSN, Novitium Pharma, Somerset Therap, Specgx Llc, Teva Pharms Inc, Torrent, Zenara, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from eighteen suppliers. Additional details are available on the PRUCALOPRIDE SUCCINATE profile page.

The generic ingredient in PRUCALOPRIDE SUCCINATE is prucalopride succinate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.

Summary for 219180

Tradename:	PRUCALOPRIDE SUCCINATE
Applicant:	Micro Labs
Ingredient:	prucalopride succinate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jun 29, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jun 29, 2026	TE:	AB	RLD:	No

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