Drug application

ATROPINE SULFATE (ATROPINE SULFATE)

Drugs@FDA ANDA 219996 · GLAND

Key facts

Drug name ATROPINE SULFATE
Active ingredients ATROPINE SULFATE
Application type ANDA
Application number 219996
Company GLAND
Dosage forms SOLUTION/DROPS, OPHTHALMIC
Strength 1%
Marketing status Prescription
TE codes AT1
Reference listed drug No
Latest submission status date Jul 31, 2026

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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