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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021876
Company: DUCHESNAY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLEGIS DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/31/2022 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
06/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf
09/30/2013 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
04/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf
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