Details for New Drug Application (NDA): 204376
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NDA 204376 describes DUTASTERIDE, which is a drug marketed by Acella, Actavis Labs Fl Inc, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Graviti Pharms, Heritage Pharms Inc, Hikma, Humanwell Puracap, Onesource Specialty, Ph Health, Pharmobedient, Rising, Strides Pharma, Zydus Lifesciences, Aurobindo Pharma, and Zydus Pharms, and is included in twenty-three NDAs. It is available from eleven suppliers. Additional details are available on the DUTASTERIDE profile page.
The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 204376
| Tradename: | DUTASTERIDE |
| Applicant: | Graviti Pharms |
| 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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