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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204816

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NDA 204816 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, and Zydus Pharms, and is included in twelve 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 204816

Tradename:	SILODOSIN
Applicant:	Zydus Pharms
Ingredient:	silodosin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	4MG
Approval Date:	Dec 8, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	8MG
Approval Date:	Dec 8, 2022	TE:		RLD:	No

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