Drug application

LEVULAN (AMINOLEVULINIC ACID HYDROCHLORIDE)

Drugs@FDA NDA 020965 · SUN PHARM INDS INC

Key facts

Drug name LEVULAN
Active ingredients AMINOLEVULINIC ACID HYDROCHLORIDE
Application type NDA
Application number 020965
Company SUN PHARM INDS INC
Dosage forms SOLUTION, TOPICAL
Strength 20%
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Dec 3, 1999

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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