Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080225
Company: FRESENIUS KABI USA
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
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 3MEQ/ML INJECTABLE;INJECTION Prescription None No 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
06/30/1971 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
12/06/1994 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/13/1993 SUPPL-52 Labeling

Label is not available on this site.

11/25/1992 SUPPL-51 Labeling

Label is not available on this site.

04/26/1991 SUPPL-50 Labeling

Label is not available on this site.

12/18/1990 SUPPL-49 Labeling

Label is not available on this site.

06/01/1990 SUPPL-48 Labeling

Label is not available on this site.

12/06/1994 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/27/1984 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/01/1984 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/13/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/01/1982 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-34 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 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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