Drug application

METHYLENE BLUE (METHYLENE BLUE)

Drugs@FDA ANDA 215636 · ZYDUS LIFESCIENCES

Key facts

Drug name METHYLENE BLUE
Active ingredients METHYLENE BLUE
Application type ANDA
Application number 215636
Company ZYDUS LIFESCIENCES
Dosage forms SOLUTION, INTRAVENOUS
Strength 10MG/2ML (5MG/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Dec 5, 2023

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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