Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220788
Company: ASPIRO
Company: ASPIRO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 5MEQ/10ML (0.5MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 10MEQ/10ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/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 |
|---|---|---|---|---|---|---|---|
| 04/15/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM BICARBONATE
SOLUTION;INTRAVENOUS; 5MEQ/10ML (0.5MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 5MEQ/10ML (0.5MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220788 | ASPIRO |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 5MEQ/10ML (0.5MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211091 | EXELA PHARMA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 5MEQ/10ML (0.5MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202679 | HOSPIRA |
SOLUTION;INTRAVENOUS; 10MEQ/10ML (1MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 10MEQ/10ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220788 | ASPIRO |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 10MEQ/10ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211091 | EXELA PHARMA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 10MEQ/10ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202495 | HOSPIRA |
SOLUTION;INTRAVENOUS; 50MEQ/50ML (1MEQ/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217523 | AMNEAL |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 219701 | ANTHEA PHARMA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220788 | ASPIRO |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211091 | EXELA PHARMA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206688 | FRESENIUS KABI USA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202432 | HOSPIRA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202494 | HOSPIRA |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203449 | INTL MEDICATION SYS |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216042 | LONG GROVE PHARMS |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216364 | OMNIVIUM PHARMS |
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217594 | STERISCIENCE |