Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211087
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | 2.98GM/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 |
---|---|---|---|---|---|---|---|
09/09/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211087Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2021 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
POTASSIUM CHLORIDE 10MEQ
INJECTABLE;INJECTION; 14.9MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS PHARMS |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
INJECTABLE;INJECTION; 746MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ
INJECTABLE;INJECTION; 29.8MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS PHARMS |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
INJECTABLE;INJECTION; 1.49GM/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS PHARMS |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
POTASSIUM CHLORIDE 40MEQ
INJECTABLE;INJECTION; 2.98GM/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS PHARMS |
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |