Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070618
Company: COPLEY PHARM

Products on ANDA 070618

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070618

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1987	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
01/23/2006	SUPPL-22	Labeling		Label is not available on this site.
04/14/2005	SUPPL-21	Labeling		Label is not available on this site.
07/18/2002	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/10/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2002	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/18/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
04/02/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
06/17/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/23/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/11/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/12/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/27/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/17/1989	SUPPL-1	Labeling		Label is not available on this site.