Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085870
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 03/21/1978 | 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-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2022 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/19/2004 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/22/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
POTASSIUM CHLORIDE
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 |