Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209997
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/30/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209997Orig1s000ltr.pdf |
SODIUM PHOSPHATES
INJECTABLE;INJECTION; 142MG/ML;276MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209997 | FRESENIUS KABI USA |
SODIUM PHOSPHATES IN PLASTIC CONTAINER | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018892 | HOSPIRA |