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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 211060

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NDA 211060 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 211060

Tradename:	SILODOSIN
Applicant:	Ajanta Pharma Ltd
Ingredient:	silodosin
Patents:	0

Pharmacology for NDA: 211060

Mechanism of Action	Adrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 211060

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILODOSIN	silodosin	CAPSULE;ORAL	211060	ANDA	Ajanta Pharma USA Inc.	27241-144	27241-144-01	30 CAPSULE in 1 BOTTLE (27241-144-01)
SILODOSIN	silodosin	CAPSULE;ORAL	211060	ANDA	Ajanta Pharma USA Inc.	27241-145	27241-145-01	30 CAPSULE in 1 BOTTLE (27241-145-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	4MG
Approval Date:	Dec 3, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	8MG
Approval Date:	Dec 3, 2018	TE:	AB	RLD:	No

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