Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080205
Company: HOSPIRA
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 Yes
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE;INJECTION Discontinued None 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
03/16/1972 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
10/04/2007 SUPPL-82 Labeling

Label is not available on this site.

10/15/2004 SUPPL-71 Labeling

Label is not available on this site.

11/07/2002 SUPPL-70 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/25/2002 SUPPL-69 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-66 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-65 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/20/1996 SUPPL-63 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/10/1994 SUPPL-62 Labeling

Label is not available on this site.

08/10/1993 SUPPL-61 Labeling

Label is not available on this site.

06/02/1992 SUPPL-60 Labeling

Label is not available on this site.

03/26/1992 SUPPL-59 Labeling

Label is not available on this site.

11/07/1991 SUPPL-58 Labeling

Label is not available on this site.

11/07/1991 SUPPL-57 Labeling

Label is not available on this site.

02/01/1991 SUPPL-56 Labeling

Label is not available on this site.

01/24/1992 SUPPL-55 Labeling

Label is not available on this site.

07/20/1989 SUPPL-53 Labeling

Label is not available on this site.

06/09/1989 SUPPL-52 Labeling

Label is not available on this site.

02/25/1986 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/27/1985 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/21/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/02/1982 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/09/1983 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/18/1982 SUPPL-32 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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