Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216920
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 03/15/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM ACETATE
SOLUTION;INTRAVENOUS; 40MEQ/20ML (2MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216920 | HIKMA |
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 018893 | HOSPIRA |
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214805 | MILLA PHARMS |
SOLUTION;INTRAVENOUS; 100MEQ/50ML (2MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216920 | HIKMA |
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 018893 | HOSPIRA |
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214805 | MILLA PHARMS |
SOLUTION;INTRAVENOUS; 200MEQ/100ML (2MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216920 | HIKMA |
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 018893 | HOSPIRA |
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214805 | MILLA PHARMS |