Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206574
Company: ASCENT PHARMS INC
Company: ASCENT PHARMS INC
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 |
---|---|---|---|---|---|---|---|
10/21/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/10/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
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 | WAYLIS THERAP |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 206373 | ACELLA |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204376 | ADAPTIS |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 203118 | AMNEAL PHARMS |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 206574 | ASCENT PHARMS INC |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 202660 | AUROBINDO PHARMA LTD |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 090095 | BARR |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 200899 | BIONPHARMA |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 209909 | HUMANWELL PURACAP |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204262 | STRIDES PHARMA |
DUTASTERIDE | DUTASTERIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 204373 | ZYDUS LIFESCIENCES |