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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019439
Company: SCHERING

Products on NDA 019439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/1986	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2008	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019439s022ltr.pdf
02/21/2001	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/01/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/21/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/15/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/08/1993	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/20/1990	SUPPL-15	Labeling		Label is not available on this site.
08/08/1989	SUPPL-14	Labeling		Label is not available on this site.
03/15/1989	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/1990	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/15/1989	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/26/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/04/1988	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/05/1988	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/1988	SUPPL-3	Labeling		Label is not available on this site.
08/12/1987	SUPPL-2	Labeling		Label is not available on this site.
08/23/1988	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019439

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2008	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf

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