Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085870
Company: B BRAUN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/21/1978 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
03/19/2004 SUPPL-20 Labeling

Label is not available on this site.

10/07/2002 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/24/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/05/1992 SUPPL-15 Labeling

Label is not available on this site.

02/22/1990 SUPPL-14 Labeling

Label is not available on this site.

07/22/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/22/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-3 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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