Details for New Drug Application (NDA): 204376
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The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 204376
Tradename: | DUTASTERIDE |
Applicant: | Adaptis |
Ingredient: | dutasteride |
Patents: | 0 |
Pharmacology for NDA: 204376
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204376
Suppliers and Packaging for NDA: 204376
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DUTASTERIDE | dutasteride | CAPSULE;ORAL | 204376 | ANDA | MARKSANS PHARMA LIMITED | 25000-011 | 25000-011-03 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03) |
DUTASTERIDE | dutasteride | CAPSULE;ORAL | 204376 | ANDA | MARKSANS PHARMA LIMITED | 25000-011 | 25000-011-07 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 7, 2017 | TE: | AB | RLD: | No |
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