Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088901
Company: FRESENIUS KABI USA

Products on ANDA 088901

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088901

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
12/02/2022	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
11/03/2022	SUPPL-33	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/21/2007	SUPPL-24	Manufacturing (CMC)-Facility		Label is not available on this site.
01/16/2007	SUPPL-23	Labeling		Label is not available on this site.
10/18/2005	SUPPL-21	Labeling		Label is not available on this site.
03/06/1997	SUPPL-16	Labeling		Label is not available on this site.
06/25/1992	SUPPL-15	Labeling		Label is not available on this site.
03/19/1991	SUPPL-14	Labeling		Label is not available on this site.
02/04/1991	SUPPL-13	Labeling		Label is not available on this site.
12/18/1990	SUPPL-12	Labeling		Label is not available on this site.
01/25/1991	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/17/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/29/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/17/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/20/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/20/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088901

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	Yes	AP	080205	HOSPIRA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	217704	NEXUS PHARMS
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