Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202509
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202509Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/26/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |