Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211232
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/27/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ETHACRYNIC ACID
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EDECRIN | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | Yes | AB | 016092 | BAUSCH |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 205609 | ADAPTIS |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 211809 | AGNITIO |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 208805 | AMNEAL PHARMS CO |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 213240 | CHARTWELL RX |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 211719 | LUPIN LTD |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 211232 | SCIEGEN PHARMS INC |
ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET;ORAL | Prescription | No | AB | 212417 | UPSHER SMITH LABS |