Dutasteride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is Dutasteride.
| Product ID | 72578-019_34c3fc15-f5d0-4948-ab0a-82541c8e06ab |
| NDC | 72578-019 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dutasteride |
| Generic Name | Dutasteride |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-04-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204373 |
| Labeler Name | Viona Pharmaceuticals Inc |
| Substance Name | DUTASTERIDE |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-04-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204373 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-15 |
| Marketing Category | ANDA |
| Application Number | ANDA204373 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-15 |
| Ingredient | Strength |
|---|---|
| DUTASTERIDE | .5 mg/1 |
| SPL SET ID: | f57c7ab3-3345-48e8-83cb-bec02da3d23c |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0395 | Dutasteride | Dutasteride |
| 0115-1438 | Dutasteride | Dutasteride |
| 0591-2292 | Dutasteride | Dutasteride |
| 25000-011 | Dutasteride | Dutasteride |
| 31722-131 | Dutasteride | Dutasteride |
| 42543-139 | Dutasteride | Dutasteride |
| 42806-549 | Dutasteride | Dutasteride |
| 50090-2285 | Dutasteride | dutasteride |
| 50090-3040 | Dutasteride | Dutasteride |
| 50090-4010 | Dutasteride | Dutasteride |
| 50268-282 | Dutasteride | Dutasteride |
| 51013-190 | Dutasteride | Dutasteride |
| 51407-157 | Dutasteride | Dutasteride |
| 51991-749 | DUTASTERIDE | DUTASTERIDE |
| 53345-037 | Dutasteride | Dutasteride |
| 60429-935 | Dutasteride | dutasteride |
| 60505-3877 | Dutasteride | dutasteride |
| 62112-8068 | Dutasteride | dutasteride |
| 63187-657 | Dutasteride | Dutasteride |
| 63629-1222 | Dutasteride | Dutasteride |
| 63629-1223 | Dutasteride | Dutasteride |
| 63629-8207 | Dutasteride | Dutasteride |
| 64380-763 | Dutasteride | Dutasteride |
| 64980-224 | DUTASTERIDE | dutasteride |
| 68071-4237 | Dutasteride | Dutasteride |
| 68071-4609 | Dutasteride | Dutasteride |
| 68071-4607 | Dutasteride | Dutasteride |
| 68071-4821 | Dutasteride | Dutasteride |
| 68382-641 | Dutasteride | Dutasteride |
| 70518-1966 | Dutasteride | Dutasteride |
| 70771-1347 | Dutasteride | Dutasteride |
| 71205-039 | Dutasteride | Dutasteride |
| 65162-750 | Dutasteride | Dutasteride |
| 72578-019 | Dutasteride | Dutasteride |
| 71205-278 | Dutasteride | Dutasteride |
| 70518-2256 | Dutasteride | Dutasteride |
| 70518-2378 | Dutasteride | Dutasteride |
| 72865-140 | Dutasteride | Dutasteride |
| 0173-0712 | AVODART | dutasteride |