Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 204373
Company: CADILA
Company: CADILA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/04/2017 | ORIG-1 | Approval |
Label is not available on this site. |
DUTASTERIDE
CAPSULE;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVODART | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021319 | GLAXOSMITHKLINE |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 202808 | ACTAVIS LABS FL INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 203118 | AMNEAL PHARMS |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204292 | APOTEX INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 206574 | ASCENT PHARMS INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 202660 | AUROLIFE PHARMA LLC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 090095 | BARR |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 200899 | BIONPHARMA INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204373 | CADILA |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 207935 | HERITAGE PHARMS INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 202204 | HIKMA |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 209909 | HUMANWELL PURACAP |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 206373 | INTERGEL PHARMS INC |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204376 | MARKSANS PHARMA |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204262 | STRIDES PHARMA |
| DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 202421 | VINTAGE PHARMS LLC |
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