Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088908
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
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 No AP 080225 FRESENIUS KABI USA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE;INJECTION Prescription No AP 080205 HOSPIRA
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

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