Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020161
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 745MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 14.9MG/ML INJECTABLE;INJECTION Prescription AP Yes No
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 1.49GM/100ML INJECTABLE;INJECTION Prescription AP Yes No
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 29.8MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 2.24GM/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 2.98GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1992 ORIG-1 Approval Type 3 - New Dosage Form 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
11/01/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/2001 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/11/1998 SUPPL-8 Labeling

Label is not available on this site.

08/11/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/11/1998 SUPPL-6 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/11/1998 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

09/24/1999 SUPPL-4 Labeling

Label is not available on this site.

08/27/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-2 Labeling

Label is not available on this site.

08/05/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 745MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE 745MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020161 ICU MEDICAL INC

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 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

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

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 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 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 30MEQ IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

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 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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