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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 211731

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NDA 211731 describes SILODOSIN, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from thirteen suppliers. Additional details are available on the SILODOSIN profile page.

The generic ingredient in SILODOSIN is silodosin. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the silodosin profile page.

Summary for 211731

Tradename:	SILODOSIN
Applicant:	Alembic
Ingredient:	silodosin
Patents:	0

Pharmacology for NDA: 211731

Mechanism of Action	Adrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 211731

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILODOSIN	silodosin	CAPSULE;ORAL	211731	ANDA	Alembic Pharmaceuticals Limited	46708-405	46708-405-30	30 CAPSULE in 1 BOTTLE (46708-405-30)
SILODOSIN	silodosin	CAPSULE;ORAL	211731	ANDA	Alembic Pharmaceuticals Limited	46708-405	46708-405-90	90 CAPSULE in 1 BOTTLE (46708-405-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	4MG
Approval Date:	Nov 22, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	8MG
Approval Date:	Nov 22, 2019	TE:		RLD:	No

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