Drugs@FDA document

DEXLANSOPRAZOLE Pediatric Statistical Review · ANDA 202294 ORIG-1

Drugs@FDA document · PH HEALTH · Jan 1, 1900

Key facts

Drug name DEXLANSOPRAZOLE
Document type Pediatric Statistical Review
Application ANDA202294
Submission ORIG-1
Company PH HEALTH
Document date Jan 1, 1900
FDA document accessdata.fda.gov

At a glance

  • 1–9 Documents for this application
  • None USP chapters cited in this application's documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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:

Browse all Drugs@FDA documents