Details for New Drug Application (NDA): 209745
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NDA 209745 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.
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 209745
| Tradename: | SILODOSIN |
| Applicant: | Amneal Pharms Co |
| Ingredient: | silodosin |
| Patents: | 0 |
Pharmacology for NDA: 209745
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 209745
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SILODOSIN | silodosin | CAPSULE;ORAL | 209745 | ANDA | AvKARE | 42291-777 | 42291-777-30 | 30 CAPSULE in 1 BOTTLE (42291-777-30) |
| SILODOSIN | silodosin | CAPSULE;ORAL | 209745 | ANDA | AvKARE | 42291-778 | 42291-778-90 | 90 CAPSULE in 1 BOTTLE (42291-778-90) |
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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