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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017533
Company: CHEPLAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KLONOPIN CLONAZEPAM 0.5MG TABLET;ORAL Prescription AB Yes No
KLONOPIN CLONAZEPAM 1MG TABLET;ORAL Prescription AB Yes Yes
KLONOPIN CLONAZEPAM 2MG TABLET;ORAL Prescription AB Yes No
KLONOPIN CLONAZEPAM 0.125MG TABLET;ORAL Discontinued None No No
KLONOPIN CLONAZEPAM 0.25MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2021 SUPPL-61 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf
02/05/2021 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf
10/25/2017 SUPPL-59 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf
10/25/2017 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf
12/16/2016 SUPPL-58 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf
12/16/2016 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf
03/25/2016 SUPPL-55 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf
03/25/2016 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf
10/31/2013 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf
09/01/2010 SUPPL-48 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010 SUPPL-46 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
04/23/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf
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