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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011559
Company: ENDO OPERATIONS

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/1960 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/011559s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/011559Orig1s057ltr.pdf
04/27/2017 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011559Orig1s051ltr.pdf
12/15/2014 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.
09/22/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
01/23/2014 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011559Orig1s045ltr.pdf
05/05/2008 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011559s041ltr.pdf
05/27/2004 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf
03/14/2003 SUPPL-33 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf
07/13/2001 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf
12/17/1997 SUPPL-30 Labeling

Label is not available on this site.
01/30/1998 SUPPL-29 Efficacy-New Route Of Administration

Label is not available on this site.
01/30/1998 SUPPL-28 Efficacy-New Route Of Administration

Label is not available on this site.
07/25/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
02/29/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
11/02/1995 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/14/1994 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1992 SUPPL-21 Labeling

Label is not available on this site.
12/18/1992 SUPPL-18 Labeling

Label is not available on this site.
07/08/1988 SUPPL-14 Labeling

Label is not available on this site.
07/01/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
10/04/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
05/14/1976 SUPPL-9 Labeling

Label is not available on this site.
06/13/1975 SUPPL-8 Labeling

Label is not available on this site.
12/11/1969 SUPPL-4 Labeling

Label is not available on this site.

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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