Details for New Drug Application (NDA): 203118
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NDA 203118 describes DUTASTERIDE, which is a drug marketed by Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Heritage Pharms Inc, Hikma, Humanwell Puracap, Norvium Bioscience, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Aurobindo Pharma, Endo Operations, and Zydus Pharms, and is included in twenty-three NDAs. It is available from sixteen 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 203118
| Tradename: | DUTASTERIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | dutasteride |
| Patents: | 0 |
Pharmacology for NDA: 203118
| Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203118
Suppliers and Packaging for NDA: 203118
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DUTASTERIDE | dutasteride | CAPSULE;ORAL | 203118 | ANDA | Amneal Pharmaceuticals LLC | 65162-750 | 65162-750-03 | 30 CAPSULE in 1 BOTTLE (65162-750-03) |
| DUTASTERIDE | dutasteride | CAPSULE;ORAL | 203118 | ANDA | Amneal Pharmaceuticals LLC | 65162-750 | 65162-750-09 | 90 CAPSULE in 1 BOTTLE (65162-750-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Nov 20, 2015 | TE: | AB | RLD: | No | ||||
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