Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208663
Company: STERIMAX
Company: STERIMAX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/09/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ETHACRYNATE SODIUM
INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EDECRIN | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 016093 | BAUSCH |
ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205473 | ENDO OPERATIONS |
ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204634 | MYLAN INSTITUTIONAL |
ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208663 | STERIMAX |
ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207758 | ZYDUS PHARMS |