Drugs@FDA document

SIVEXTRO Letter · NDA 205436 SUPPL-15

Drugs@FDA document · CUBIST PHARMS LLC · Mar 3, 2026

Key facts

Drug name SIVEXTRO
Document type Letter
Application NDA205436
Submission SUPPL-15
Company CUBIST PHARMS LLC
Document date Mar 3, 2026

At a glance

  • Labeling-Package Insert, Labeling-Patient Package Insert Document categories
  • 10–99 Documents for this application
  • 10–99 USP chapters cited in this application's documents

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About Drugs@FDA documents

Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

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