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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018163
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESTORIL TEMAZEPAM 15MG CAPSULE;ORAL Prescription AB Yes No
RESTORIL TEMAZEPAM 30MG CAPSULE;ORAL Prescription AB Yes Yes
RESTORIL TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription AB Yes No
RESTORIL TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/13/2023 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf
02/05/2021 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf
02/06/2019 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018163s065lbl.pdf
12/16/2016 SUPPL-64 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf
12/16/2016 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf
11/08/2010 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf
02/25/2008 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf
02/25/2008 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf
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