TheraRadar
Data updated: May 26, 2026

CROMOLYN SODIUM

Ophthalmology Approved 1994-04-26

CROMOLYN SODIUM is indicated for the treatment of Vernal Keratoconjunctivitis; Vernal Conjunctivitis; Vernal Keratitis.

Source: FDA Label • GENERA PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
21
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Discontinued
First Approved
1994-04-26
Routes
ORAL, OPHTHALMIC, NASAL, INHALATION
Dosage Forms
CONCENTRATE, SOLUTION/DROPS, SPRAY, METERED, SOLUTION

Companies

GENERA PHARMS Apotex HH AND P MICRO LABS LTD INDIA FERA PHARMS LLC MICRO LABS EUGIA PHARMA BAUSCH AND LOMB RISING Teva WOCKHARDT BIO AG WATSON LABS AILEX PHARMS LLC SCIEGEN PHARMS ROXANE BAUSCH Hikma PERRIGO Novartis
Active Ingredient: CROMOLYN SODIUM

CROMOLYN SODIUM Approval History

1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
53 FDA actions from 1994 to 2025
Oct 2025 SUPPL
Mfg · Manufacturing (CMC)
Dec 2023 SUPPL
Mfg · Manufacturing (CMC)
Nov 2023 SUPPL
Label · Labeling

What CROMOLYN SODIUM Treats

3 indications

CROMOLYN SODIUM is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Vernal Keratoconjunctivitis
  • Vernal Conjunctivitis
  • Vernal Keratitis
Source: FDA Label

Drugs Similar to CROMOLYN SODIUM

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

VERKAZIA
CYCLOSPORINE
1 shared
HARROW EYE
Shared indications:
Vernal Keratoconjunctivitis
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Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT07526558 24-0990 Ph 2 not yet recruiting Mast Cell Treatment in Post-tick Bite Illness (PTBI)
NCT05077917 E21197 Ph 3 terminated Cromolyn Sodium for Treatment of COVID-19 Pneumonia
NCT01933464 results posted 130199 Ph 1, Ph 2 completed An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
NCT01841307 13-11080 Ph 1 terminated Cromolyn Detection of Silent Aspiration
NCT02566252 PUL-042-003 Ph 1 completed Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)
NCT00745199 4146 Ph 2 completed Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CROMOLYN SODIUM FDA Label Details

Indications & Usage

FDA Label (PDF)

CROMOLYN SODIUM is indicated for the treatment of Vernal Keratoconjunctivitis; Vernal Conjunctivitis; Vernal Keratitis.

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INTAL

Full clinical data, patents, trials, and competitive landscape for cromolyn sodium.

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Data Sources

FDA Approval: ANDA090954 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.