Last Updated: November 10, 2026

Details for New Drug Application (NDA): 204726

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NDA 204726 describes SILODOSIN, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Lupin, Macleods Pharms, MSN, Pharmazone, 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the silodosin profile page.

Summary for 204726

Tradename:	SILODOSIN
Applicant:	Chartwell Rx
Ingredient:	silodosin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	4MG
Approval Date:	Mar 31, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	8MG
Approval Date:	Mar 31, 2017	TE:	AB	RLD:	No

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