Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088908
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2MEQ/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 |
|---|---|---|---|---|---|---|---|
| 01/25/1985 | 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 |
|---|---|---|---|---|---|
| 12/02/2022 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2022 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2007 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/08/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/06/2005 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/19/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/15/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/25/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 085870 | B BRAUN |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080205 | HOSPIRA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217704 | NEXUS PHARMS |
| POTASSIUM CHLORIDE IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088901 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088908 | FRESENIUS KABI USA |