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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018708
Company: GALT PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORAL QUAZEPAM 15MG TABLET;ORAL Prescription None Yes Yes
DORAL QUAZEPAM 7.5MG TABLET;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/13/2023 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf
01/13/2023 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf
02/05/2021 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018708s027lbl.pdf
02/06/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018708s025lbl.pdf
12/16/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf
04/19/2013 SUPPL-21 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/19/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/19/2013 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/13/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf
10/30/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf
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