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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017892
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALCION TRIAZOLAM 0.25MG TABLET;ORAL Prescription AB Yes Yes
HALCION TRIAZOLAM 0.5MG TABLET;ORAL Discontinued None No No
HALCION TRIAZOLAM 0.125MG TABLET;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-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017892s057lbl.pdf
10/27/2021 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s056lbl.pdf
02/05/2021 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s055lbl.pdf
10/09/2019 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s050lbl.pdf
02/06/2019 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s054lbl.pdf
12/16/2016 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf
12/16/2016 SUPPL-49 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf
09/18/2014 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf
02/12/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf
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