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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077419
Company: ACTAVIS LABS FL INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/02/2008 ORIG-1 Approval Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077419Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/10/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
02/26/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
11/22/2010 SUPPL-13 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/02/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203106 UPSHER SMITH LABS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 077419 ACTAVIS LABS FL INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208864 ADARE PHARMS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214686 GRANULES
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203002 LUPIN LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204828 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200185 PADAGIS US
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209026 PRINSTON INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205549 STRIDES PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208445 ZYDUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203106 UPSHER SMITH LABS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 077419 ACTAVIS LABS FL INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208864 ADARE PHARMS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202128 AMNEAL PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202868 GLENMARK PHARMS LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214686 GRANULES
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203002 LUPIN LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204828 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200185 PADAGIS US
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209026 PRINSTON INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205549 STRIDES PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208445 ZYDUS PHARMS
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