Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080225
Company: FRESENIUS KABI USA

Products on ANDA 080225

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080225

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.