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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013263
Company: WAYLIS THERAP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALIUM DIAZEPAM 2MG TABLET;ORAL Prescription AB Yes No
VALIUM DIAZEPAM 5MG TABLET;ORAL Prescription AB Yes No
VALIUM DIAZEPAM 10MG TABLET;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/14/2023 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf
03/14/2023 SUPPL-98 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf
01/13/2023 SUPPL-97 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263s097lbl.pdf
02/05/2021 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013263s096lbl.pdf
12/16/2016 SUPPL-94 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf
12/16/2016 SUPPL-94 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf
10/22/2013 SUPPL-92 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf
05/12/2008 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf
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