Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210473
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP2 | No | Yes |
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP2 | 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 |
---|---|---|---|---|---|---|---|
01/15/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210473Orig1s000ltr.pdf |
EPOPROSTENOL SODIUM
INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP2 | 210473 | SUN PHARM |
VELETRI | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP2 | 022260 | ACTELION |
INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP2 | 210473 | SUN PHARM |
VELETRI | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP2 | 022260 | ACTELION |