Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202679
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM BICARBONATE | SODIUM BICARBONATE | 0.5MEQ/ML | 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 |
---|---|---|---|---|---|---|---|
03/07/2017 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/14/2021 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/29/2017 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
SODIUM BICARBONATE
INJECTABLE;INJECTION; 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 | 0.5MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211091 | EXELA PHARMA |
SODIUM BICARBONATE | SODIUM BICARBONATE | 0.5MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202679 | HOSPIRA |
SODIUM BICARBONATE | SODIUM BICARBONATE | 0.5MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202981 | HOSPIRA |