TheraRadar
Data updated: Nov 8, 2026

OPTICROM (cromolyn sodium) · AbbVie

Respiratory Approved 1984-10-03

OPTICROM is FDA-approved to treat 3 conditions (same as CROMOLYN SODIUM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Discontinued
First Approved
1984-10-03
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

AbbVie
Active Ingredient: CROMOLYN SODIUM

OPTICROM Approval History

1985
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Original
New Indication
New Form
Label Update
24 FDA actions from 1984 to 2003 · 1 indication expansions
Mar 2003 SUPPL
Label · Labeling
Apr 2002 SUPPL
Mfg · Manufacturing (CMC)
Dec 2001 SUPPL
Mfg · Manufacturing (CMC)

What OPTICROM Treats

3 indications

OPTICROM is approved for 3 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Vernal Keratoconjunctivitis
  • Vernal Conjunctivitis
  • Vernal Keratitis

Same approved indications as CROMOLYN SODIUM (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

7 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
NCT07675876 CS CROM-LC-001 Ph 1 not yet recruiting Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer
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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.

OPTICROM FDA Label Details

Indications & Usage

OPTICROM is FDA-approved to treat 3 conditions — same approved indications as CROMOLYN SODIUM.

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Data Sources

FDA Approval: NDA018155 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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