Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075604
Company: ACTAVIS LABS FL INC

Products on ANDA 075604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75604.ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2008	SUPPL-15	Labeling		Label is not available on this site.
12/24/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
10/09/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
11/29/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075604

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KLOR-CON M10	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	074726	UPSHER SMITH LABS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	075604	ACTAVIS LABS FL INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076368	ADARE PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214422	ASCENT PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	203562	GLENMARK PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214452	GRANULES
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214395	GUANGZHOU NOVAKEN
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	216269	MACLEODS PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	206347	NOVEL LABS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209922	PRINSTON INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	216321	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210395	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KLOR-CON M20	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	074726	UPSHER SMITH LABS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	075604	ACTAVIS LABS FL INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	076368	ADARE PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214422	ASCENT PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	203562	GLENMARK PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214452	GRANULES
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	214395	GUANGZHOU NOVAKEN
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	216269	MACLEODS PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	206347	NOVEL LABS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209922	PRINSTON INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	216321	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210395	ZYDUS PHARMS