Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011559
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREVITAL SODIUM METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
BREVITAL SODIUM METHOHEXITAL SODIUM 2.5GM/VIAL INJECTABLE;INJECTION Discontinued None Yes No
BREVITAL SODIUM METHOHEXITAL SODIUM 5GM/VIAL INJECTABLE;INJECTION Discontinued None No No
BREVITAL SODIUM METHOHEXITAL SODIUM 200MG/VIAL INJECTABLE;INJECTION Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/03/2020 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/011559s057lbl.pdf
04/27/2017 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf
01/23/2014 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf
05/05/2008 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf
05/27/2004 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf

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