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Abbreviated New Drug Application (ANDA): 211087
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
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