Drug application

MIDAZOLAM (MIDAZOLAM)

Drugs@FDA ANDA 216048 · CIPLA LTD

Key facts

Drug name MIDAZOLAM
Active ingredients MIDAZOLAM
Application type ANDA
Application number 216048
Company CIPLA LTD
Dosage forms SPRAY, NASAL
Strength 5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Nov 1, 2022

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

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

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

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

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