Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208122
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | 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 |
---|---|---|---|---|---|---|---|
07/23/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
11/05/2020 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018016 | BAXTER HLTHCARE |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 208122 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019759 | HOSPIRA |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018090 | ICU MEDICAL INC |