Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209382
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TREPROSTINIL | TREPROSTINIL | 1MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
| TREPROSTINIL | TREPROSTINIL | 2.5MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
| TREPROSTINIL | TREPROSTINIL | 5MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
| TREPROSTINIL | TREPROSTINIL | 10MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209382Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2022 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |