Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020649
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EDEX | ALPROSTADIL | 0.005MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| EDEX | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| EDEX | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| EDEX | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| EDEX | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| EDEX | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| EDEX | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/09/2015 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf | |
| 06/09/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf |