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Last Updated: March 29, 2024

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, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, and Zydus Pharms, and is included in twelve NDAs. It is available from twelve 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. Thirteen 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 ActionAdrenergic 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:RXDosage:CAPSULE;ORALStrength4MG
Approval Date:Dec 3, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength8MG
Approval Date:Dec 3, 2018TE:ABRLD:No

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