Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087584
Company: LUITPOLD

Products on ANDA 087584

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087584

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1981	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
11/07/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/06/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/28/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/22/1991	SUPPL-16	Labeling		Label is not available on this site.
05/06/1991	SUPPL-15	Labeling		Label is not available on this site.
07/29/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/02/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/11/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/27/1991	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/12/1991	SUPPL-10	Labeling		Label is not available on this site.
01/13/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/13/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/13/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/17/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/23/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.