Details for New Drug Application (NDA): 021319
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The generic ingredient in AVODART is dutasteride. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dutasteride profile page.
Summary for 021319
Tradename: | AVODART |
Applicant: | Waylis Therap |
Ingredient: | dutasteride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021319
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021319
Suppliers and Packaging for NDA: 021319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AVODART | dutasteride | CAPSULE;ORAL | 021319 | NDA | Waylis Therapeutics LLC | 80725-712 | 80725-712-04 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04) |
AVODART | dutasteride | CAPSULE;ORAL | 021319 | NDA | Waylis Therapeutics LLC | 80725-712 | 80725-712-15 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 20, 2001 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021319
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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