Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214805
Company: MILLA PHARMS
Company: MILLA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM ACETATE | SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (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 |
|---|---|---|---|---|---|---|---|
| 05/04/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214805Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2024 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
SODIUM ACETATE
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 |
INJECTABLE;INJECTION; 400MEQ/100ML (4MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | INJECTABLE;INJECTION | 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 |
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 |